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Investigation Operations Manual…
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[Index]
Contents
SUBCHAPTER 520 - EVIDENCE DEVELOPMENT
SUBCHAPTER 520 - EVIDENCE DEVELOPMENT
520 - TECHNIQUES
The recognition, collection, and effective presentation of admissible
evidence is essential to successful litigation. Tangible evidence is
required to support your observations and reports of violative conditions.
Although the inspectional procedures to detect adulteration and contamination,
etc., are described under specific headings in the IOM, the same procedures
and/or techniques may also apply to other areas. For instance, the procedures
to detect contamination from filth, insects, rodents, birds, etc., described
in IOM 530 may also apply to drugs or other products. Your experience
and training assists you in making this transition and enables you to
detect possible violative conditions.
Keep in mind the policy annunciated in the 4/23/1991 memorandum from
the Director, Office of Compliance: The lack of a violative physical
sample is not a bar to pursuing regulatory and/or administrative action
providing the CGMP deficiencies have been well documented. Likewise,
physical samples found to be in compliance are not a bar to pursuing
action under CGMP charges.
521 - FACTORY SAMPLES
Samples of raw materials or finished products collected during inspections
provide the necessary key to establish routes of contamination. They
also document the character of products packed prior to the inspection.
Collect Factory Samples for laboratory examination only when they contribute
to confirming the suspected violation. Be selective since negative reports
of analysis of food samples are required under Section 704(d) of the
FD&C Act [21 U.S.C. 374 (d)] and might give management a false picture
of the firm's operation.
When possible collect duplicate sub samples to provide for the 702(b)
portion of the sample. See IOM
422.01 & 427.04f
for additional guidance and 21 CFR 2.10 for exemptions regarding the
collection of duplicate portions.
522 - EXHIBITS
Impressive exhibits are extremely effective and important forms of evidence
to establish existence of violative conditions or products. They should
relate to insanitary conditions contributing or likely to contribute,
filth to the finished product, or to practices likely to render the product
injurious or otherwise violative. Diagrams of the establishment, floor
plans, flow charts, and schematics are useful in preparing a clear concise
report and in later presentation of testimony. A small compass is useful
in describing exact locations of objectionable conditions in the plant,
in your diagrams, and locations from which samples were taken, etc. See IOM
Exhibit 510-C.
Describe and submit under one INV Sample Number all exhibits (except
photographs) collected during the inspection or investigation. Identify
and number individual subs and officially seal all samples collected.
Examples of exhibits include:
Apparatus - Four dram size glass vials, 95% ethanol, and cotton swabs
preformed on 6" long wooden handles. Keep uncontaminated in a clean plastic
bag.
Procedure - Blow away loose dirt or debris from approximately a 3" x
3" selected area. Measure approximately 2 cm of 95% ethanol in vial,
dip swab into ethanol, press out excess on inside of vial and roll moist
swab back and forth firmly across the selected area. Return swab to vial,
swirl in alcohol, press out excess on inside of vial and again roll moist
swab across the same area 90° to the previous swabbing. Re-insert
swab into vial, break off swab handle and cap the vial with the swab
inside.
When swab sub-samples are submitted, also submit a blank control sub
consisting of an unused swab placed in a capped vial containing 2 cm
of the same alcohol that was used for the other swabs.
Describe the type of material swabbed (cardboard carton, metal table
top, rubber inspection belt, etc.) and the area covered. A reasonable
area is approximately 10 sq. inches. Always try to establish a definite
link in the chain of subsamples leading towards the highest level of
contamination. If possible, identify the pesticide suspected. Be sure
to include a floor plan with the areas sampled identified.
523 - PHOTOGRAPHS - PHOTOCOPIES
Photos taken during EI's are not classified as INV Samples. They
are exhibits. No C/R is used for photos taken unless the photos are part
of an Official Sample. See IOM
405 for information on Official Samples.
Since photographs are one of the most effective and useful forms of
evidence, every one should be taken with a purpose. Photographs should
be related to insanitary conditions contributing or likely to contribute
filth to the finished product, or to practices likely to render it injurious
or otherwise violative.
CAUTION: Evaluate the area where flash photography is contemplated.
Do not use flash where there is a potentially explosive condition; e.g.
very dusty areas or possible presence of explosive or flammable vapors.
In these situations use extremely fast film and/or long exposure time
instead of flash.
Examples of conditions or practices effectively documented by photographs
include:
When photographing labels, make sure your picture will result in a legible
label with printing large enough to be read by an unaided eye. Photograph
whited out documents by holding a flashlight against the whited out side
and taking a close up photo of the reverse using high-speed film. This
will produce a photo with a mirror image of the whited out side.
If you use a Polaroid camera or color slide film, explain the facts
in your EIR or on the C/R to alert reviewers that there are no negatives.
523.01 - In-Plant Photographs
Do not request permission from management to take photographs during
an inspection. Take your camera into the firm and use it as necessary
just as you use other inspectional equipment.
If management objects to taking photographs, explain that photos are
an integral part of an inspection and present an accurate picture of
plant conditions. Advise management the U. S. Courts have held that photographs
may lawfully be taken as part of an inspection.
If management continues to refuse, provide them with the following references:
If management refuses, advise your supervisor so legal remedies may
be sought to allow you to take photographs, if appropriate. If you have
already taken some photos do not surrender film to management. Advise
the firm it can obtain copies of the photos under the Freedom of Information
Act. See IOM
523.03.
523.02 - Photo Identification and Submission
One of the most
critical aspects about photographs or videotapes is the ability for
the agency to provide testimony clearly verifying the authenticity
of the conditions depicted in the photograph or video. It makes no
difference if the photo is a 35 mm print from acetate negatives, a
Polaroid photo, a digital photo or video taken with a video recorder.
You must create a trail, starting with the taking of the photo, confirming
its original accuracy and establishing a record describing the chain
of custody. To do this, you must make sure each photograph is described
in your diary or regulatory notes in sufficient detail to assure positive
correlation of the photo or video with your inspection findings. One
way you can do this is to photograph a card with your name, district
address and phone number as the first frame or picture on a roll of
film or in the digital record. This will help identify the film or
file and assist in tracking if it is lost or becomes separated from
its identification envelope during processing or storage. Proper procedures
will also allow the agency to provide evidence confirming the authenticity
of the photographs or video recording in the event you are not able
to testify personally.
523.021 - Preparing and Maintaining Digital Photographs as Regulatory
Evidence
A digital photo's chain of custody (and authenticity) must be assured
and protected with the following procedure:
523.03 - Photograph Requests
Do not routinely advise firms they may have copies of photos. However,
if management of the firm initiates the request, advise them it is possible
to obtain copies of photographs taken in their plant under the Freedom
of Information Act. Any request should be sent to The Food and Drug Administration,
at the address listed on the FDA 482 or FDA 483. The firm must bear the
cost of duplicating the photographs.
Since photographs are records in an investigative file, they are not
available under the Freedom of Information Act until the file is closed.
Do not discourage firms from taking their own photographs at the same
time and of the same scenes as you.
524 - RECORDINGS
Under normal circumstances recording devices will not be used while
conducting inspections and investigations. However, some firms are now
recording and/or video taping, the inspection and/or the discussion with
management portion of the inspection. These firms should be advised we
do not object to this procedure, but we will also record the discussion
to assure the accuracy of our records. Occasionally a firm's management
may record the serving of an inspection warrant or, in a hostile situation,
may want to record everything. In such cases, depending on the circumstances,
you may prepare your own recording in parallel with the firm's recording.
Do not depend on the firm to provide a duplicate of their recordings.
Use a clear tape cassette and identify the tape verbally as follows:
"This is Investigator ____________ of the U.S. Food and Drug Administration
speaking in the (state location) of (firm name), (address), (city), (state),
and (zip code). It is now a.m./p.m. on (date). Present are (list individuals
present with title). This discussion is being recorded by both the representative
of (firm name) and by me. We are going to discuss the inspectional findings
of an inspection conducted at this firm on (inclusive dates)."
At the close of the discussion and prior to leaving the firm, the recording
will be verbally identified as follows:
"This is Investigator ____________ speaking. It is now _______ a.m./p.m.
on (date). This was a recording of the discussion with management at
the conclusion of an inspection of (firm name & address) conducted
on (dates).
If the recording covers a different situation, the identification should
be modified accordingly. If the representative of the firm refuses permission
to record the discussion, continue with your discussion and report the
facts in your EIR.
The tape cassette must be identified with the firm name, date of the
inspection, and investigator's name. Districts have the option of
transcribing the tape and making the transcription an exhibit for the
EIR. However, the tape itself must be made a permanent part of the EIR
as an exhibit.
525 - RESPONSIBLE INDIVIDUALS
The identification of those responsible for violations is a critical
part of the inspection, and as important as determining and documenting
the violations themselves. Responsibility must be determined to identify
those persons to hold accountable for violations, and with whom the agency
must deal to seek lasting corrections.
Document and fully report individual responsibility whenever;
Under the Medical Device Quality System regulation (21 CFR 820.20),
if the management at the firm is not exercising the controls required
by the regulation, the deviations may be cited on your FDA 483.
525.01 - Discussion on Duty, Power, Responsibility
Duty - An obligation required by one's position; a moral or legal
obligation.
Power - Possession of the right or ability to wield force or influence
to produce an effect.
Responsibility - An individual who has the duty and power to act is
a responsible person.
Three key points to consider are:
525.02 - Inspection Techniques How to Document Responsibility
Always determine and report the full legal name and title of persons
interviewed, who supplied relevant facts and the name/title/address of
top management officials to whom FDA correspondence should be directed.
Obtain the correct name and correct title of all corporate officers
or company officials. Obtain pertinent educational and experience backgrounds,
and the duties and powers of the officers and employees in key managerial,
production, control, and sanitation positions. Ascertain the experience
and training of supervisory personnel, in terms that will describe their
qualifications to carry out their responsibilities.
There are numerous ways to establish and document responsibility. Evidence
may be obtained during interviews and record review specifically intended
to determine responsibility. Cover and report items such as:
In order to establish relationships between violative conditions and
responsible individuals, the following types of information, would be
useful:
Duties and power related to general operations should be established
to supplement the specific relationships to violations. Examples of operational
decisions that indicate responsibility are:
In some circumstances, documenting of individual responsibility requires
investigative techniques that lead to sources outside the firm. These
sources may include contractors, consultants, pest control or sanitation
services, local health officials and others. Copies of documents between
the firm and outside parties may help establish responsibilities. Do
not overlook state officials as another possible source of information
in selected cases.
During the course of the inspection you may observe persons who hold
responsible positions and/or influence in the firm whose abilities or
judgment may be affected by an obvious infirmity, handicap, or disability.
If it is obvious the infirmity adversely affects the person's responsibilities
or duties that are under FDA oversight, describe in your EIR the extent
of the infirmity and how it relates to the purported problem or adverse
condition.
526 - GUARANTEES AND LABELING AGREEMENTS
Review the Code of Federal Regulations, 21 CFR 7.12, 7.13, 101.100(d),
201.150, and 701.9, for information concerning guarantees and labeling
agreements.
Guaranty - Certain exemptions from the criminal provisions of the FD&C
Act are provided where a valid guarantee exists as specified in Section
303(c) of the FD&C Act [21 U.S.C. 333 (c)]. Obtain a copy of any
Food and Drug guarantee, which the firm claims to use relating to a violation
noted during your inspection. No person may rely upon any guaranty unless
he has acted merely as a conduit through which the merchandise reached
the consumer.
Labeling Agreement - Products regulated by FDA are normally expected
to be completely labeled when introduced into or while in interstate
commerce. Under certain conditions exemptions are allowed when such articles
are, in accordance with trade practices, to be processed, labeled, or
repacked in substantial quantity at an establishment other than where
originally processed or packed. Sections 405, 503(a) and 603 of the FD&C
Act [21 U.S.C. 345, 353(a), and 363] also provide exemptions from complete
labeling for products.
To enjoy this exemption, the shipment must meet one of the following:
Submit copies and dates of labeling agreements where unlabeled articles
are shipped in interstate commerce.
527 - RECORDS OBTAINED
Many types of inspections and investigations require collection of copies
of records to document evidence of deviations. In some cases, this may
involve voluminous copies of Good Manufacturing Practice (GMP) records,
commitments made in the Pre-Approval process, adherence to the requirements
of the Low Acid Canned Food regulations or other areas. Copies of records
are also obtained to document interstate commerce, product labeling and
promotion, and to identify the party or parties responsible for a variety
of actions. All documents become part of the government's case should
it go to litigation.
Normally, during litigation proceedings, the best evidence rule prevails
in court, whereby the copy of the record in the custody of the government
can be authenticated, if the original record is not produced by the custodian
of the record.
It is imperative the government witness [usually the collector of the
record(s)] be able to testify where, when and from whom the copies were
obtained, and that the copy is a true copy of the source document, based
on their review of the source document.
527.01 - Identification of Records
Articles used as evidence in court cases must be marked to assure positive
identification. This includes all records as noted in IOM
527, and any others for evidence in administrative or judiciary proceedings.
When identifying and filing records, you must assure the record is complete
and no identification method or filing mechanism covers, defaces or obliterates
any data on the record/document.
It is imperative you identify the records used as evidence so you can
later testify the documents entered as evidence are the very ones you
obtained. See IOM 527.2. You should always review source documents to
assure the records you obtained are an accurate representation (copy)
of the source document. Record in your Regulatory Notes the when, where,
and from who copies are obtained so you can properly prepare for testimony
as needed.
527.02 - Identifying Original Paper Records
NOTE: Policy Changes - In keeping with other regulatory and enforcement
agencies' policies, the mandatory identification of the original
or source document copied during an inspection or investigation is no
longer routinely required. IOM
451.05 covers identification of records collected and submitted as
part of a sample collection.
When you collect an Official or Documentary (or "DOC") Sample, each
page of the copied records will become part of the collection report
and should be identified as noted in this section and as in IOM
430.05. This includes records of interstate commerce, manufacturing
deviations, label and labeling violations, or any other record copied
which may become "evidence.
While it is no longer routinely required for you to identify the original
or source record(s), you must verify the copy of the record(s) you received
is an accurate reproduction of the original or source record(s). You
must be able to testify your copy is an exact duplicate of the original
or source record. You should record in your diary you authenticated copies
of records you obtain so you can provide this testimony during any trial
proceedings.
To ensure you are able to positively identify the specific copies you
received during your inspection or investigation and to avoid any filing
mix-up, you must identify the copies you obtained. This identification
will cover records submitted in support of the inspection or investigation,
and include all those submitted whether it is an Establishment Inspection
Report (EIR) or a narrative memorandum.
You should identify records/exhibits submitted with an EIR using at
least the Exhibit number, firm name, date(s) of the inspection, and your
initials. This should be done in such a way that you will be able to
clearly identify the copy of specific record(s) you obtained. If some
type of label is used, it must be permanently applied so any removal
will be obvious. Records submitted with a Collection Report will be similarly
identified with the sample number, date of collection, but with your
handwritten initials. Records submitted with a memorandum will include
a phrase or firm or subject name to tie them to the investigation, the
date(s) of the investigation and your initials.
There are occasions when a single record may include hundreds of sheets
of bound paper. Abbreviated methods of identification may be used for
bound documents by fully identifying the first and last few pages. In
some cases, firm's clearly mark each page with the sequential and
total pages number (e.g., page 6 of 10, 7 of 10, etc.) and this allows
you to fully mark only a few pages in the beginning and end of the exhibit.
All pages must be identifiable if not in bound documents. One example
of a shortened method of identifying individual exhibits containing a
large number of pages (usually more than 25) is to fully identify the
first few and last few pages with at least the exhibit number, date and
your initials. Then identify the remaining pages with the page number
of the total page numbers, and your initials, e.g., "5 of 95 SHR". This
may not be acceptable if you have more than one exhibit consisting of
exactly 95 pages.
Whatever method is used, you must assure the document is complete and
is always identifiable. This is so you can testify as to the "where", "when" and "from
whom" the copies were obtained, and that the copy is a true copy of the
source document based on your review of the source document. The identification
method should allow any reviewer to determine if the document is complete
or pages or parts are missing.
527.03 - Filmed or Electronic Records
When attempting to obtain records, you may find they are stored on microfilm,
microfiche, or some form of a computerized management information system
as electronic records.
Microfilm/Microfiche and electronic information - You may encounter
records stored on microfilm/microfiche or as electronic records on a
computer system. Hard copy records obtained during the course of the
inspection from these sources are handled the same as any hard copied
records following procedures outline in IOM
527, 527.01 and 527.02.
NOTE: See CPG Section 130.400 for Agency Policy concerning microfilm
and/or microfiche records. 21 CFR Part 11 contains information concerning
Electronic Records and Electronic Signatures and may be of value to you.
Electronic information received on CD-R, or other electronic storage
media - You may obtain electronic information, databases, or summary
data from a firm's databases during an establishment inspection.
The methods used must maintain the integrity of the electronic data and
prevent unauthorized changes.
Electronic data, such as blood bank databases, drug production records,
medical device complaints, service records, returned products and other
records are often dynamic data files with real time updating. Information
from these files is generally provided at the time of the inspection.
Your request may require the firm to develop one or more custom queries
to provide the requested information. You must assume the query logic
is not validated and take appropriate action to ensure the data is accurate
and no data has been accidentally omitted due to a programming logic
error occurring at the firm.
When appropriate, a copy of electronic data can be obtained on one or
more CD-R, or other electronic storage media. If you provide the diskettes
to the firm, use only new, previously unused and preformatted diskettes.
An additional safeguard is to request the firm reformat the disk on their
own computer to assure it is usable and "clean".
Any request for electronic information on a CD-R, or other electronic
storage media must be made with a computer application in mind and the
data obtained must be useful. Request for electronic information should
be in a format compatible with software applications knowledgeable to
you and available from the Agency. Converting files into different file
formats is difficult and should not be attempted without the necessary
knowledge and availability of conversion type programs where applicable.
If help is needed for file conversion, assistance may be available within
the district, region or from DFI HFC-130.
Any CD-R or other electronic storage media containing electronic information
received during the course of an inspection should be considered and
handled as master copies. The firm may or may not retain a copy of the
information provided during the course of an inspection. Ask the individual
providing the copy(s) to provide actual CD-R or other electronic storage
media labeling information, such as filename(s), date and other information
to facilitate their later identification of the CD-R or other electronic
storage media and the data provided on the CD-R or other electronic storage
media. The name of the appropriate software and version used to ensure
readability of the information should also be maintained with the copy
of the electronic information.
You should perform a virus scan of the master CD-R or other electronic
storage media according to Agency requirements. Each master diskette
should be write-protected, labeled and identified as you would any hard
copy document.
There are no guarantees the files provided on CD-R or other electronic
storage media will be useable data. It is your responsibility to make
a working copy of each master CD-R or other electronic storage media.
Before making any working copies from the master CD-R or other electronic
storage media, confirmation should be made that the write-protection
has been activated on each master diskette. You will need to use a computer
to view the copied files and verify each file contains the information
requested and the information is useable to you. Some electronic data
files may be too large to open from a CD-R or other electronic storage
media and must be loaded on a hard disk before opening. If this is the
case, the file should be put on a subdirectory before opening and viewing.
As a general practice, any findings developed from electronic information
provided by the firm should be requested in a hard copy format. The hard
copy provided by the firm should then be used as an exhibit to support
the investigator's observation. This will preclude or limit any errors
that may have occurred from the investigator querying of the electronic
information.
The master CD-R, diskettes or other electronic storage media , should
be secured to assure the integrity of the data when used in a subsequent
enforcement action. Identify the master copy as an exhibit, write-protect
diskettes, and place in a suitable container, e.g., FDA-525, and officially
seal. Mark the FDA-525 or other container as containing diskettes and
to "Protect from magnetic fields." The diskette(s) should be stored as
part of the exhibits with the original EIR. See IOM
594.01.
527.04 - Requesting and Working with Computerized Complaint and Failure
Data
The auditing of FDA regulated firms has found that an increasing number
of firms are developing and maintaining computerized complaint and failure
data to meet GMP record requirements. Records, hardcopy and electronic,
are becoming increasingly voluminous. The auditing of information contained
in computerized databases is generally most effectively accomplished
with the use of a computer.
Computer auditing of computerized complaints and failure data may require
the transfer of electronic data to CD-R or other electronic storage media
for you to use in your computer. You should use a computer and application
software familiar to you to query information obtained in electronic
format. You should not use the audited firm's equipment or personnel
to perform extensive queries or manipulation of the audited firm's
own computerized data.
527.041 - Computerized Complaint and Failure Data
Requesting and obtaining electronic data on CD-R or other electronic
storage media is becoming more common during the course of routine inspections.
Providing computerized data on electronic media is advantageous to both
you and the firm and can result in shorter inspection time. These types
of databases contain large numbers of records, which can be easily and
quickly queried if they are in electronic format. Inspection time would
be lengthened if all such information was only provided in hardcopy format.
It may result in you reentering all of the hardcopy data into a new database
or reviewing volumes of documents. Be aware if the firm should generate
custom software to provide requested electronic records, it would be
difficult for you to validate or verify the firm's algorithm used
to extract the requested data and ensure that records were not accidentally
or deliberately omitted due to programming logic errors, data entry errors,
etc.
527.042 - Requesting Computerized Data
Before requesting a copy of computerized data, you should determine
several things including information about the size and contents of the
database, the program used by the firm, and the program you will use,
among others. The following steps are useful in preparing for an electronic
record request.
527.043 - Identification and Security of CD-R, Diskettes or Other Electronic
Storage Media
You should follow these steps to ensure proper identification and security
of CD-R or other electronic storage media:
1. Label each CD-R or other electronic storage media
a. Firm name
b. Date and your initials
c. Initials by a representative of the firm (optional)
If you provide the diskettes to be used, use only new and preformatted
diskettes from an unopened box.
d. The name of the appropriate software and version to ensure readability
of the information
2. Make a working copy of CD-R or other electronic storage media
a. Write protect the original diskette
b. Virus scan the original diskette
c. Copy the original CD-R or other electronic storage media
The original CD-R or other electronic storage media should not be used
for manipulating data so as to maintain the integrity of the CD-R or
other electronic storage media and data. NOTE: If a virus is detected,
do not remove the virus from the source diskette provided by the firm.
This may become evidence if it is suspected that the firm intentionally
transferred the virus. Attempt to obtain another, uninfected copy of
the data file from the firm.
Create a subdirectory on the computer hard drive
527.044 - Data Integrity of Records Provided by Firm
Many manufacturers are using computers to store records concerning complaints,
failure data, returned goods, servicing, testing results and others.
Record traceability and data integrity are always concerns when you copy
or use computerized data.
527.045 - Electronic Information for Official Documentation
During your use of queried data, if you find a violative situation,
you should request the firm prepare a hardcopy report of the specific
data that depicts the situation. (Do not request an entire copy of the
data base and do not rely on the digital database or your extractions
from the data to serve as official documentation.) Any records of interest,
such as complaints, failure information, etc., noted from querying the
computerized data should be copied from original hardcopy documents to
support the findings in the database. You should also maintain the procedures
or commands you used to find the violative situations in the data base.
Follow procedures in IOM
527.03 for maintaining and identifying original disks.
527.05 - Listing of Records
If management requests a list of the copies of records you obtain, prepare
it in duplicate and leave the original with the firm. Many firms prepare
duplicate copies of documents requested during our inspections. In the
interests of conserving inspectional time, you may ask the firm to prepare
the list of copies concurrently with the photocopying and you then verify
the accuracy. Do not use form FDA-484, Receipt for Samples. Describe
the circumstances in your report including the name and title of the
individual to whom you gave the list. Submit the duplicate list with
your report as an Exhibit.
527.06 - Patient and/or Consumer Identification on Records
During the course of many types of inspections and investigations you
will review and collect records which specifically identify (by name)
patients or consumers. Under most state Privacy Laws this information
is confidential. Some firms we inspect may mistakenly believe this information
is not releasable to the federal government. However, Federal laws preempt
State laws; with few exceptions we are entitled to review and copy the
complete record, including the identifying patient/consumer names. The
Agency is then required to maintain the confidentiality of the records/files,
as with any confidential record you collect. Any disclosure of the information
contained in the record(s) can only be by Law, i.e., judge's order,
disclosure, Congressional order, etc.
General, routine guidance is as follows:
b. For methadone inspections, continue the Agency policy of deleting
patient identification specific to the patient (name, SSN, Driver License
#, etc.).
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