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Investigation Operations Manual…
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[Index]
Contents
SUBCHAPTER 510 - INSPECTION PROCEDURES
SUBCHAPTER 510 - INSPECTION PROCEDURES
510 - PRE-INSPECTIONAL ACTIVITIES
Prior to the start of any inspection or investigation,
Prior to initiating any inspection
you should become familiar with the reporting requirements for the
specific assignment, as well as the requirements of IOM Sub-Chapter
590.
If the inspection or investigation is a directed assignment from a
Center, ORA headquarters or another district, read it and attached
materials to assure you understand the assignment. If the inspection
or investigation is being conducted in part or solely as a recall follow-up
or complaint, refer to Chapter
8 (Recalls) or Chapter
9 (Investigations) of the IOM for additional guidance.
You should also review the applicable Compliance Program Guidance Manual(s)
prior to the start of your inspection or investigation. ORA's Division
of Field Investigations (DFI) has written numerous Inspection Guides
to assist you in conducting inspections of various types of establishments,
products or processes. You should become familiar with the appropriate
guides prior to the start of the inspection and utilize them as needed
throughout the inspection. The Centers have issued numerous guidance
documents for industry. These documents are normally posted to the appropriate
Center's Internet and Intranet web sites. Detailed references are
listed by program area in Chapter
10 of the IOM.
Sub-chapters 530-570 of
the IOM contain additional, program specific pre-inspectional activities,
which you should follow.
Imported products cross all program areas and our regulation of them
does not stop at the border. Please be alert to imported products whenever
you make an inspection. During inspections of domestic firms, if you
encounter counterfeit imported products, returned imported products,
rejected imported products or otherwise suspect an imported product should
not have been allowed to enter the country, take some time to investigate
the source of the imported products. Determine the port of entry and
/or the importer if possible. Using the FEI number of the consignee,
importer or manufacturer, import personnel can determine the importing
pattern of a firm and alert the appropriate ports.
Pre-Announcements - Pre-announcements are mandatory for all medical
device inspections in accordance with the criteria and instructions below
and BIMO sponsor/monitor inspections. In all other program areas, pre-announcements
may be made at the discretion of the district. If you are going to visit
facilities where livestock (including poultry) or wild animals are housed
or processed, review IOM
519. In general, it may be inappropriate to pre-announce inspections
of food establishments, blood banks, source plasma establishments and
some BIMO inspections, but this too is subject to district discretion.
If a district believes pre-announcing an inspection of an establishment
will facilitate the inspection process then the procedures below for
doing pre-announcements for medical device inspections should be followed.
ORA's primary purpose for pre-announcing is to assure the appropriate
records and personnel will be available during the inspection. It is
not to make an appointment for the inspection. It should not be referred
to as an appointment to inspect. When doing a pre-announcement, it is
important you communicate to the establishment the purpose of the inspection
and a general idea of the records you may wish to review. If you find
neither the appropriate personnel nor records available, note this in
your Establishment Inspection Report (EIR). The District may use this
data in the future when considering whether this establishment should
be eligible for pre-announced inspections.
The following is the general outline for pre-announcement of medical
device inspections. You are advising the establishment's management
of the date and time you will be arriving at the establishment to conduct
the inspection. The establishment has no authority to negotiate this.
If you, as the investigator, feel the need to accommodate the establishment's
request, be sure there are sound reasons for doing so and report them
in your inspection report.
A. Basic Premises
When deciding whether an establishment qualifies for a pre-announced
inspection, you must consider whether both the type of inspection and
the establishment's status meet the following specific criteria.
Include in your EIR whether or not the inspection was pre-announced
and include information on any difficulties experienced in notification
or accessing records or personnel, which should have been available as
a result of pre-announcing the inspection. For medical device establishment
inspections, if not pre-announced, describe briefly in the EIR why not.
If an establishment should become ineligible for pre-announcement, the
endorsement of the EIR should include this statement. This information
will be necessary for making a determination regarding future pre-announced
inspections of the establishment. In addition, it is advisable to inform
the establishment during the current and subsequent inspections of the
action(s), which may have caused them to be ineligible for pre-announcement.
Sub-chapters 530-570 of
the IOM contain additional, program specific pre-inspectional activities,
which you should follow.
510.01 - Personal Safety
Physical resistance to FDA inspections
and threats to, or assaults on, FDA employees engaged in their work
are extremely rare. However, there will be times you are confronted
by unfriendly or hostile persons. ORA has offered various conflict
resolution training courses to assist and prepare you for how to diffuse
a situation. In most instances, conducting your activities with tact,
honesty, diplomacy, and persuasiveness will be enough to diffuse the
situation. While at times, you may have to adopt a firm posture, you
should not resort to threats, intimidation, or strong-arm tactics.
Refer to IOM
514.01 for Hostile and Uncooperative Interviewees.
Safety is the responsibility
of all FDA employees, including you, your supervisor and other Agency
management. When you receive an assignment, it is important to evaluate
the assignment not only in accordance with IOM
Section 510, but also with respect to your personal safety. If
you determine there is the possibility of a threat to your personal
safety, consult with your supervisor. You and your supervisor should
consider developing a Situational Plan in preparation for the inspection.
Below are some suggested items
the District may consider when preparing for your next assignment to
assess if there are potential personal safety issues. This list is
not meant to be all inclusive.
If these questions and/or others
result in a concern for your personal safety, then a Situational Plan
should be developed and approved by District management before conducting
the assignment. See IOM
510.03 – Situational Plan
Due to the unlimited variability
of potential safety situations, it is not feasible to prescribe in
the IOM what to do in every instance. The decision of what to do in
each individual circumstance rests with the Investigator and their
District management. Your district management is most familiar with
the specific firm in question, the regulated industry, as well as other
local Federal, State and Local officials who may be able to provide
you additional information and assistance. In addition, the experience
of your District management combined with the various training courses
on conflict resolution may also be consulted. Districts should notify
Division of Field Investigations to inform headquarters of any potential
safety concern, so that DFI may track personal safety issues. DFI will
also maintain a library of Situational Plans which may also be of use
to your District. DFI may be contacted at (301) 827-5653 or at the
following personal safety e-mail address:
Physical Resistance/Threats/Assaults:
If you receive physical resistance or threats, or if you sense the
real possibility of an assault, disengage from the confrontation, get
to safety, and call your supervisor immediately. Make careful and exact
notes later of who said what to whom, who did what, and whether someone
tried or succeeded in threatening, assaulting or taking information
or equipment or samples from you. Be careful in any descriptions you
give or write of such events, just as you are in recording other evidence
that may result in a court case. Your safety is more important to the
United States than the inspection or the sample. FDA will work with
law enforcement government officials, e.g. FDA's Office of Criminal
Investigations' (OCI) Special Agents, local police, or United States
Marshals to assist an inspection team if there is a reasonable fear
of danger to the investigator.
If you are assaulted (either
physically or put in fear by threats of physical violence), your supervisor
can summon local police, United States Marshals, FBI or contact OCI
headquarters for assistance (301-294-4030). While OCI does not normally
provide physical security in these cases, they will assist in threat
evaluation based on specific facts and available data bases. OCI can
also make contacts with local police and federal agencies based on
previous established liaisons. If you have been assaulted or threatened
and you are unable to reach your supervisor or other District management,
you should contact the local police in the area where the assault or
threat occurred. Be careful in any descriptions you give or write of
such events, just as you are in recording other evidence that may result
in a court case. Make sure that any inspected facility where weapons
are observed, or where threats or assaults occur, is identified on
that facility's Endorsement page of the inspection report for that
facility and to your supervisor, so that Investigators or Agents who
follow you into that facility will be alert to those possibilities.
Your supervisor would also be responsible for checking the Personal
Safety Alert box in FACTS and for beginning the notification process
to alert other Federal or State agencies that also inspect the facility
of the possible danger. For more information See IOM
510.02 Personal Safety Alert. For specific safety guidance related
to inspections and interviews, see IOM
514.01 Hostile and Uncooperative Interviewees.
510.02 - Personal Safety Alert
In any example listed where there
is a Personal Safety Alert, the specific safety alert should be documented
both in the Endorsement and in a Memo to the File. The memo should
be flagged “MEMO TO FILE — PERSONAL SAFETY ALERT” and
should provide the factual information to support why the Investigator
should be alerted to the safety issue. Be careful in any descriptions
you give or write of such events, just as you are in recording other
evidence that may result in a court case. The memo should be filed
in the official establishment file jacket and copies be sent to any
and all Resident Posts and Import Offices who may interact with the
firm. The memo will be filed on the opposite side of the folder from
all other documents and will be a printed on eye-catching color paper
in order for the document to be visible to the next Investigator. The
memo should be retained and maintained at the District Office. A copy
of the Memo documenting the personal safety situation should also be
sent to Division of Field Investigations, HFC-130. The Supervisor and/or
other District management will be responsible for evaluating any corrective
actions taken by the firm or individual to remove or stop the potentially
dangerous situation or condition. If the situation remains potentially
dangerous, the Personal Safety Alert should be maintained in FACTS.
Follow-up inspections at the facility should continue to document whether
or not the safety situation continues exists. If the situation has
been resolved (new management, dismissal of an employee, cessation
of penicillin in a facility), than the Personal Safety Alert should
be removed from FACTS.
510.03 - Situational Plan
There are four principles to
a Situational Plan. These are:
The situational plan should be
developed by the Investigator, Supervisor, other CSO’s who may
be familiar with the facility, Compliance Officer, if needed, and any
other individuals (District experts etc.) who may be able to assist
in the depth, scope, and specifics of the firm in question. The decision
of who should be involved in the development and approval of the plan
is left to the Districts’ discretion.
District management and all involved
in writing the Situational Plan should meet when necessary in order
to assure a well developed, and understood Situational Plan. You and
your supervisor should maintain contact during the execution of the
Situational Plan. The Supervisor should contact the employee during
these personal safety situations at a predetermined frequency outlined
in your plan. A debriefing session should be held following the execution
of the Situational Plan. This debriefing session should be held with
all those who were involved in the development and execution of the
plan. Discussions should include what actions worked well and where
there are areas of improvement.
For foreign inspections where
a situational plan is warranted, DFI will assist the inspection team.
The inspection team’s management may also wish to participate
so that there is a clear understanding of what actions will be taken
for the foreign inspection.
A copy of completed and executed
Situational Plans must be sent to DFI (HFC-130) in order for DFI to
maintain a reference library of all situational plans.
See Exhibit 510-D of this section,
an example of questions that an Investigator and/or Supervisor may
wish to consider when establishing a situational plan.
511 - NOTICE OF INSPECTION
Upon arrival at the firm locate the owner, operator or agent in charge
of the establishment. This should be the top Management Official on site.
Be certain of this individual's status. Introduce yourself by name,
title and organization. Show your credentials to this person and present
a properly signed, completed, original of the FDA 482, Notice of Inspection,
including the attachment page "Resources for FDA Regulated Businesses".
This attachment provides information for the firm in the event it has
disagreements or complaints. See IOM Exhibit
510-A1.
If additional Agency personnel accompany you during the inspection,
they must show their credentials to the top Management Official upon
arrival at the site. A new FDA 482, Notice of Inspection must be issued.
Submit the carbon copy of the FDA 482(s) with your EIR. Explain the purpose
of your visit. Readily accept any management offer to have a representative
accompany you on the inspection.
For multiple occupancy inspections in drug establishments, refer to IOM
501.04. Inspections of multiple firms, which are separate legal
entities, should be reported under separate EIRs.
If faced with a refusal, or partial refusal of inspection proceed as
outlined in IOM
514.
Any time a FDA 482 is issued, also issue FDA 484, Receipt for Samples,
if you collect any samples at the firm. See IOM
513. See IOM
401.01 & 401.02 for
instructions for issuance of the FDA 482 in certain sampling situations.
See IOM 401.01 for
issuance of a FDA 482 for sample collections only. The FDA 482 may be
amended "To Collect Samples Only" as shown in IOM Exhibit
510-A2.
If you have concerns of when to or when not to issue the FDA 482, discuss
with your supervisor.
511.01 - Multiple Date Inspections
If your inspection covers more than one day, advise management at the
close of each day you have not finished the inspection and when you will
return. Do this each day until you finish the inspection. A FDA 482 is
not required for each day of an inspection or when different individuals
are interviewed. If there will be an extended period of time (i.e., a
week or longer) before you can return to the firm to complete the inspection,
be sure management is aware of the delay and discuss with your supervisor
whether or not you need to issue another FDA 482.
511.02 - Inspection of Vehicles
If vehicles are present which are owned or leased by the firm being
inspected and it is necessary to inspect the vehicles, the inspection
of these is covered by the FDA 482, Notice of Inspection, you issued
to the firm.
If vehicles (trucks, trailers, RR cars, etc.) which are not owned or
leased by the firm are present and inspection is necessary, a separate
FDA 482, Notice of Inspection, is required:
511.03 - Follow-Up Inspections by Court Order
At times you may be instructed to conduct inspections of firms by authority
of an injunction or other court order. This situation provides separate
and distinct inspectional authority involving both the authority of the
court order and the authority of Section 704 of the FD&C Act [21 U.S.C.
374], each providing independent courses of action.
When assigned to conduct inspections under these situations, obtain
a copy of the injunction or other court order bearing the filing stamp
and all relevant signatures. Prior to starting the inspection study the
order thoroughly for any special instructions of the court. Your supervisor
will assist you in determining the depth of the inspection necessary
to cover all of the court requirements.
Take a clearly legible copy of the court decree (not necessarily a certified
copy) with you to the firm to be inspected.
Present your credentials in the same manner as for any other EI. Issue
the FDA 482, Notice of Inspection, modified to read, "Notice of Inspection
is hereby given under authority of injunction (provide here the injunction
number and/or other identification) against the firm and pursuant to
Section 704 ***". Show the person to whom the FDA 482 was issued a copy
of the Order, and, read the following statement to that person.
"This inspection is being conducted under the authority of injunction
(add the injunction number and/or other identification) (or other court
order) granted by the United States District Court against this firm
on (date). The inspection will cover all items specified in the decree.
In addition to the inspection authority granted in the court decree,
I am issuing you a Notice of Inspection under the authority of Section
704 of the Federal Food, Drug and Cosmetic Act which authorizes inspections
of firms subject to that Act."
If, the firm refuses access to records, facilities, or information for
which the decree provides inspectional authority, read the pertinent
section(s) or portion of the order to the person refusing so there will
be no misunderstanding as to the requirements of the decree. If the person
still refuses, report the facts to your supervisor as soon as possible
so the court can be promptly advised of the situation. See IOM
514 for information on handling refusals.
At the conclusion of the inspection and a FDA 483 is to be issued and
you are using Turbo EIR, follow the Turbo instructions to get injunction
specific cites on the FDA 483.
When you prepare your EIR, describe the sequence of events in detail
including exactly what happened and how you handled the situation. This
documentation will help support any charge of violating the court order
and/or Section 704 of the FD&C Act [21 U.S.C. 374].
The court order may require a report to the court. Discuss this with
your supervisor since the district will normally handle this part of
the requirement.
511.04 - Conducting Regulatory Inspections When the Agency is Contemplating
Taking, or is Taking, Criminal Action
You should not issue a Notice of Inspection if the agency is contemplating
taking, or is taking, criminal action against a firm without first discussing
the matter with your Supervisory Investigator. Federal Rules of Evidence
may not permit using evidence in a criminal matter if it is knowingly
obtained under administrative authorities such as Section 704 of the
FD&C Act [21 U.S.C. 374]. It is the responsibility of the office
generating the inspection assignment to inform the District if a criminal
action is ongoing or contemplated. Once alerted, the Supervisory Investigator
will then obtain advice from the Office of Chief Counsel and, once obtained,
will assign the inspection to the Investigator(s).
Decisions to inspect under such circumstances should be based on considerations
of whether or not the request is consistent with FDA's responsibility
to assure articles are not produced or distributed in violation of the
Federal Food, Drug, and Cosmetic Act or other Federal law within FDA's
jurisdiction. It would be lawful to conduct an inspection to identify
such violative products and to determine if corrective action was necessary
to bring such products into compliance. However, it would be an abuse
of the regulatory inspection authority for FDA to conduct a regulatory
inspection under that authority for the sole purpose of gathering evidence
of criminal violations. Such an abuse is unlawful, and could have significant
consequences.
This is because, in general, the Fourth Amendment to the United States
Constitution prohibits searches without a warrant. One exception to the
warrant requirement includes the inspection of industries long subject
to close supervision and inspection, which are conducted under a statute
that dispenses with the need for a warrant. Because such inspections
are not subject to advance scrutiny for probable cause, as would be an
inspection conducted pursuant to a criminal warrant, the Supreme Court
has warned government entities not to use administrative inspections
to search for criminal violations in an effort to sidestep the Fourth
Amendment. So long as the Agency conducts the administrative inspection
in good faith for a valid, non-criminal purpose, evidence gathered in
such inspections generally may be used in a criminal prosecution. However,
the facts of each case are unique, and employees involved must carefully
document the Agency's purpose in conducting the inspection.
Because the Agency's underlying purpose in conducting an inspection
ultimately will determine whether the inspection was conducted in good
faith to pursue a valid, non-criminal purpose it is important to document
the non-criminal purpose for an inspection undertaken under these circumstances.
The need for and extent of such documentation is at a minimum when the
non-criminal purpose of the inspection is evident and compelling, for
example, when the purpose is to determine articles are being produced
in conformity with the Food, Drug, and Cosmetic Act. The need to document
the non-criminal purpose of the regulatory inspection increases as the
likelihood of criminal prosecution increases. For example, there would
be an increased need to document the regulatory purpose of an inspection
if the matter has been referred to the Department of Justice for grand
jury investigation.
There may be occasions when neither the office generating the inspection
assignment nor the District conducting the inspection is aware the Office
of Criminal Investigations is conducting a criminal investigation of
a firm that is the subject of a regulatory inspection. The Office of
Criminal Investigations may determine it is not in the interest of the
agency to disclose to other components of FDA the existence of its investigation,
as long as the Office of Criminal Investigations is not involved in the
agency decision to conduct a regulatory inspection. However, the Office
of Criminal Investigations and other components of FDA may also share
information as set out below.
511.05 - When Evidence of a Criminal Violation is Discovered in the
Course of a Regulatory Inspection
If you know criminal investigators are conducting a criminal investigation,
your supervisor should notify the criminal investigators of any such
observations. If you do not know of any ongoing criminal investigation,
your supervisor should refer the information for review by the Office
of Criminal Investigations. See the current Regulatory Procedures Manual
(RPM). If the regulatory inspection is Center-directed (such as a bio-research
monitoring inspection, a pre-approval inspection, or an inspection related
to data integrity issues) your supervisor should immediately notify the
Center involved of the referral to the Office of Criminal Investigations.
The discovery of evidence of a criminal violation may also be relevant
to FDA's responsibility to assure articles are being produced in
conformity with the Food, Drug, and Cosmetic Act. Additional inspections
may be warranted. Such inspections should be planned and documented in
accordance with the preceding section, "Conducting Regulatory Inspections
When the Agency is Contemplating Taking, or is Taking, Criminal Action."
511.06 - Use of Evidence Gathered in the Course of a Criminal Investigation
Information and evidence gathered in the course of a criminal investigation
may be shared with regulatory personnel, subject to two reservations:
Criminal investigators should consult their supervisors to determine
whether disclosure should be made to regulatory investigators.
511.07 - Use of Evidence Voluntarily Provided to the Agency
511.08 - Concurrent Administrative, Civil, and Criminal Actions
It may be appropriate to seek administrative and/or civil remedies against
a firm or individual under investigation for criminal violations. There
are many issues involved in determining whether such actions may proceed
concurrently, or whether certain actions should proceed first. Each situation
must be evaluated on an individual basis. If administrative and/or civil
remedies are under consideration against a firm or individual also under
investigation for criminal violations, representatives from the Center
responsible for evaluating the administrative and/or regulatory action
should meet with the Office of Criminal Investigations Headquarters staff
to issues related to the timing of administrative, civil, and criminal
actions. The Office of Criminal Investigations and other components of
FDA may share information subject to the reservations set out earlier.
511.09 - Working with a Grand Jury
Finally, if you are assigned to work with a grand jury, you should not
participate in a regulatory inspection or other regulatory matter involving
the same firm or individual(s). Such participation is contrary to long
standing agency policy, might be unlawful, and could result in sanctions
against the investigator and the agency. You should not participate in
any regulatory matters that could result in improper disclosure of grand
jury information, even after the grand jury investigation is closed.
Grand jury proceedings remain secret even after they are concluded. Under
no circumstances should you undertake such participation without first
obtaining clearance from the Department of Justice attorney or the Office
of Chief Counsel attorney assigned to the grand jury case. See IOM
705 for additional information on Grand Jury proceedings.
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