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Investigation Operations Manual…
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[Index]
Contents
SUBCHAPTER 530 - FOOD
SUBCHAPTER 530 - FOOD
530 - FOOD INSPECTIONS
Food plant inspections are conducted to evaluate the methods, facilities,
and controls used in manufacturing, storage and distribution of foods.
530.01 - Preparation and References
Before undertaking an inspection:
530.02 - Inspectional Authority
See IOM 701 for
broader information on this topic.
Authority to Obtain Records & Information in LACF & Acidified
Foods Plants:
1. Written Demand for Records - FDA's regulation
in 21
CFR 113 requires commercial processors of low-acid foods packaged
in hermetically sealed containers to maintain complete records of processing,
production and initial distribution. 21
CFR 114 requires the same of commercial processors of acidified foods. 21
CFR 108.25(g) and 21 CFR 108.35(h) provide that a commercial processor
shall permit the inspection and copying of the records required by 21
CFR 113 and 21 CFR 114 by duly authorized employees of FDA. The demand
for these records must be in writing on an FDA 482a, Demand for Records,
signed by you and must identify the records demanded.
To obtain the records:
(a) Prepare a FDA 482a, "Demand for Records", listing the records demanded.
Describe the processing records to be reviewed and/or copied as accurately
as you can, e.g., "All thermal process and production records mandated
by 21 CFR 113 (or 114 if applicable) for the foods (state name of food)
processed at this plant on (specific date or period of time)". If only
a specific record is desired list it specifically as follows: e.g., "Fill
Weight Records for #2 Filling Machine for the period 4-15-87 through
6-7-87." (b) Sign the form. (c) Issue the original to the same person
to whom the FDA 482, "Notice of Inspection", was issued. (d) Submit the
carbon copy with your EIR.
2. Written Request for Information - 21 CFR 108.35(c)(3)(ii)
states commercial processors engaged in thermal processing of low-acid
foods packaged in hermetically sealed containers shall provide FDA with
any information concerning processes and procedures necessary by FDA
to determine the adequacy of the process. 21 CFR 108.25(c)(3)(ii) requires
the same of commercial processors of acidified foods. The information
in this regulation is the data on which the processes are based. Many
processors will not have this information and in fact 21
CFR 113.83 requires only that the person or organization establishing
the process permanently retain all records covering all aspects of establishing
the process. The processor should, however, have in his files a letter
or other written documentation from a processing authority delineating
the recommended scheduled process and associated critical factors.
You may encounter situations where you believe control of certain factors
is critical to the process and there is no evidence to document these
factors were considered when the process was established (e.g., a change
in formulation which could effect consistency). It is appropriate to
issue a written request for a letter or other written documentation from
a processing authority, which delineates the recommended scheduled process
and associated critical factors. This represents the processing authority's
conclusions and should correlate with the filed process.
If you believe control of certain factors are critical to the process
and are not delineated in the process authority's recommendation
or the filed process, obtain all available information about the situation.
Include the name of the person or organization who established the process
and the specific practices of the firm. This information should be included
in your report and forwarded by your District to the Center for Food
Safety and Applied Nutrition, Division of Enforcement (HFS-605) for review,
as soon as possible. If the process establishment data and information
is deemed necessary by the center, they will either request it directly
from the processor or will direct the district to request it. If requested
to obtain the information:
530.03 - CFSAN Bio-research Monitoring
Bio-research monitoring (BiMO) assignments for foods will generally
be issued by the Center for Food Safety and Applied Nutrition (CFSAN)
(see IOM 545).
530.04 - Food and Cosmetics Defense Inspectional Activities
Inspectional activities relative
to food and cosmetic security for routine food and cosmetic establishment
inspections should include:
1. Discussion with firm management
of relevant FDA guidance documents including:
These documents should be used
as references during inspections, as appropriate. Copies may be obtained
at: http://www.fda.gov/oc/factsheets/foodsecurity.html.
If firm management does not already have a copy of the relevant guidance
documents provide them with hard copies or information on how to obtain
the guidance from FDA’s web site.
2.
Identification of opportunities for improvement or enhancement of the
firm’s food and cosmetic security preventive measures, as compared
to those recommended in the guidance documents, and encouragement of
management to make such improvements or enhancements to their security
system;
Keep in mind that: the guidance
does not represent mandatory conditions or practices; some of the recommended
food and cosmetics security preventive measures may not be appropriate
or practical to the specific operation; and other means of achieving
the goals of the preventive measures listed in the guidance may be
more suitable for the specific operation than those cited as examples.
The important message for management is to consider the goals of the
food and cosmetics security preventive measures; evaluate the goals
relative to the specifics of their operation; and address those that
are relevant to the extent practical.
Reconciliation Examinations
During Routine Food and Cosmetic
Inspections - Conduct one reconciliation examination during each
food and cosmetic establishment inspection. The examinations are
to be conducted on raw materials used in the manufacture of foods
or cosmetics, or finished products received by the firm for further
distribution. Preference should be given to products of foreign origin.
Where possible, these examinations should be performed on products
as they are received by the firm.
As Part of an Import Field
Examination and Entry Review - See IOM
620 and 632.
For imported food and cosmetics, a reconciliation examination should
be conducted: (1) as an “Add-On” to all routine import
field exams; AND, (2) in instances where review of entry information
raises suspicion (resulting in a targeted reconciliation exam).
Follow guidance below for domestic
and import reconciliation exams.
Reconciliation Examination
Guidance
PART A
If no unexplained inconsistencies are detected, no further action is indicated.
Special Safety Precautions
See IOM
Subchapters 140 Safety,
sections including 141.01 thru 141.04, and Section
143 on sampling
hazards.
530.05 - Food Registration
The owner, operator, or agent
in charge of a facility must register the facility’s name, address,
telephone number and, if available their fax number and e-mail address.
If applicable, they must register the same information for their parent
companies. They must also register emergency contact information, trade
names, general product categories, and, if a foreign facility, information
about their U.S. Agent. They can also supply optional information.
The registrant must certify the truthfulness and accuracy of the submitted
information.
The purpose of registration is
to provide sufficient and reliable information about food facilities.
When used with the detention, recordkeeping, and prior notice provisions
of the Bioterrorism Act, registration will help to provide information
on the origin and distribution of food and feed products to allow for
detection and quick reaction to real and potential threats to these
products. In the event of a potential threat or an outbreak of foodborne
illness, such information will help FDA and other authorities to notify
food facility representatives and investigate the event, source, and/or
cause of the outbreak. Also, it will enable FDA to notify quickly the
facilities that might be affected by the outbreak.
Facilities Exempted from
Registration
The Bioterrorism Act, as implemented
by the interim final rule for registration of food facilities exempts
the following from registration:
(a) A foreign facility, if food
from such facility undergoes further manufacturing/processing (including
packaging) by another facility outside the U.S. ( Note :
A facility is not exempt under this provision if the further manufacturing/processing
(including packaging) conducted by the subsequent facility consists
of adding labeling or any similar activity of a de minimis nature.
The facility conducting the de minimis activity also must register;
(b) Farms that are devoted to
the growing and harvesting of crops, the raising of animals (including
seafood), or both. Washing, trimming of outer leaves of, and cooling
produce are considered part of harvesting. The term “farm” includes:
(i) Facilities that pack or
hold food, provided that all food used in such activities is grown,
raised, or consumed on that farm or another farm under the same ownership;
and
(c) Retail food establishments
whose sales to consumers exceed their sales to non-consumers (businesses
are considered non-consumers);
(d) Restaurants that prepare
and serve food directly to consumers for immediate consumption;
(e) Nonprofit food establishments
in which food is prepared for, or served directly to, the consumer;
(f) Fishing vessels, including
those that not only harvest and transport fish but also engage in practices
such as heading, eviscerating, or freezing intended solely to prepare
fish for holding on board a harvest vessel. However, those fishing
vessels that otherwise engage in processing fish are required to register.
For the purposes of this section, "processing" means handling, storing,
preparing, shucking, changing into different market forms, manufacturing,
preserving, packing, labeling, dockside unloading, holding, or heading,
eviscerating, or freezing other than solely to prepare fish for holding
on board a harvest vessel;
(g) Facilities that are regulated
exclusively, throughout the entire facility, by the U.S. Department
of Agriculture under the Federal Meat Inspection Act (21 U.S.C. 601
et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.),
or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.)
Other exemptions from registration
in the interim final rule are based on the definition of food included
within the scope of the registration regulation. Facilities that manufacture/process,
pack, or hold food contact substances (including packaging materials)
or pesticides are exempt from registration.
Agency Website Link :
Inspectional Guidance
See
Compliance Policy Guide Sec. 110.300: Registration
of Food Facilities Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002. During
inspections of domestic and foreign facilities subject to the rule,
make sure that firm management is aware of the registration requirements.
Inform the firm's management that information regarding food
security, the BT Act, facility registration, required and optional
information, definitions, exemptions, and penalties for failure to
register, etc., is available at the following website: http://www.cfsan.fda.gov/~dms/fsbtact.html
531 - PERSONNEL
Management - Follow the guidance described in IOM
525 when documenting individual responsibility including obtaining
the full name and titles of the following individuals:
Regulations require plant management take all reasonable measures and
precautions to assure control of communicable disease, employee cleanliness,
appropriate training of key personnel, and compliance by all personnel
with all requirements of 21 CFR
110.10, 113.10,
and 114.10.
Determine if adequate supervision is provided for critical operations
where violations are likely to occur if tasks are improperly performed.
Employees - Improper employee habits may contribute
to violative practices in an otherwise satisfactory plant. Observe the
attitude and actions of employees during all phases of the inspection.
Observe employees at their work stations and determine their duties or
work functions. Note whether employees are neatly and cleanly dressed
and whether they wear head coverings which properly cover their hair.
Determine if employees working with the product have obvious colds,
or infected sores, cuts, etc. Under no circumstance should you swab a
sore, touch or remove a bandage from an employee in an attempt to obtain
bacteriological data. To do so is a violation of personal privacy, possibly
hazardous to you and/or the employee, and usually provides little useful
data.
Note whether employees eat while on duty.
Observe and record insanitary employee practices or actions showing
employees handling or touching unsanitized or dirty surfaces and then
contacting food products or direct food contact surfaces. Such practices
might include employees spitting, handling garbage, placing their hands
in or near their mouths, cleaning drains, handling dirty containers,
etc. and then handling food product without washing and sanitizing their
hands. Observe whether employees comply with plant rules such as, "No
smoking", "Keep doors closed", "Wash hands before returning to work",
etc. See IOM
536.02.
Be alert to employees handling insanitary objects, then quickly dipping
their hands in sanitizing solutions without first washing them. Depending
upon the amount and type of filth deposited on the hands during the handling
of insanitary objects, such attempts at sanitizing are questionable at
best. Sanitizers work most effectively on hands, which have been first
cleaned by washing with soap and water.
Conversations with employees doing the work may provide information
on both current and past objectionable practices, conditions and circumstances.
These should be recorded in your notes.
Where appropriate, determine employee education and training. Also determine
type, duration, and adequacy of firm's training programs, if any,
to prepare employees for their positions and to maintain their skills.
See IOM 593.03.
532 - PLANTS AND GROUNDS
Environment - Observe the general nature of the neighborhood
in which the firm is located. Environmental factors such as proximity
to swamps, rivers, wharves, city dumps, etc., may contribute to rodent,
bird, insect or other sanitation problems.
Plant Construction, Design and Maintenance - Determine
the approximate size and type of building housing the firm and if suitable
in size, construction, and design to facilitate maintenance and sanitary
operations. Check placement of equipment, storage of materials, lighting,
ventilation, and placement of partitions and screening to eliminate product
contamination by bacteria, birds, vermin, etc. Determine any construction
defects or other conditions such as broken windows, cracked floor boards,
sagging doors, etc. which may permit animal entry or harborage.
Inspect toilet facilities for cleanliness, adequate supplies of toilet
paper, soap, towels, hot and cold water, and hand washing signs. Check
if hand washing facilities are hidden, or if located where supervisory
personnel can police hand washing.
Determine who is responsible for buildings and grounds maintenance.
Many facilities such as docks, wharves, or other premises are owned and
maintained by other firms, municipalities, or individuals for lease for
manufacturing operations. Determine who is legally responsible for repairs,
maintenance, rodent proofing, screening, etc. Evaluate the firm's
attitude toward maintenance and cleaning operations.
Waste Disposal - Waste and garbage disposal poses
a problem in all food plants depending upon plant location and municipal
facilities available.
Check the effectiveness of waste disposal on the premises and ensure
it does not cause violative conditions or contribute toward contamination
of the finished products. Check for in-plant contamination of equipment
and/or product, if its water is supplied from nearby streams, springs,
lakes or wells.
Suspected dumping of sewage effluent into nearby streams, lakes, or
bay waters near water intakes can be documented by color photographs
and water soluble fluorescein sodium dye. Place approximately two ounces
dye, which yields a yellowish red color, into the firm's waste system
and/or toilets, as applicable, and flush the system. The discharge area
of the effluent becomes readily visible by a yellowish-red color on the
surface of the water as the dye reaches it. Color photographs should
be taken.
Determine collecting or flushing methods used to remove waste from operating
areas. If water is used, determine if it is recirculated and thus may
contaminate equipment or materials.
Determine the disposition of waste materials that should not be used
as human food such as rancid nuts, juice from decomposed tomatoes, etc.
Determine the disposition of waste, garbage, etc., which contain pesticide
residues. Determine how this is segregated from waste material which
contains no residues and which may be used for animal feed.
Plant Services - If applicable, check steam generators
for capacity and demand. Demand may reach or exceed the rated capacity,
which could effect adequacy of the process. Check boiler water additives
if steam comes in direct contact with foods.
Check central compressed air supply for effective removal of moisture
(condensate) and oil. Determine if any undrained loops in the supply
line exist where condensate can accumulate and become contaminated with
foreign material or microorganisms.
533 - RAW MATERIALS
Source - List in a general way the nature of raw materials
on hand. Itemize and describe those, which are unusual to you, or involved
in a suspected violation (copy quantity of contents and ingredient statements,
codes, name of manufacturer or distributor, etc.). Be alert for additives
and preservatives. Evaluate the storage of materials. Determine the general
storage pattern, stock rotation and general housekeeping. Materials should
be stored so they are accessible for inspection. Thoroughly check ceilings,
walls, ledges, and floors in raw material storage areas for evidence
or rodent or insect infestation, water dripping or other adverse conditions.
Handling Procedure - Determine if growing conditions
relative to disease, insects, and weather are affecting the raw material.
Check measures taken for protection against insect or rodent damage.
Raw materials may be susceptible to decomposition, bruising or damage,
e.g., soft vegetables and fruits delivered in truckload lots. Determine
the holding times of materials subject to progressive decomposition.
Condition - Evaluate the firm's acceptance examination
and inspection practices including washing and disposition of rejected
lots. Where indicated, examine rejected lots and collect appropriate
samples and report consignees.
Determine the general acceptability of raw materials for their intended
use and their effect on the finished product. Raw stocks of fruits or
vegetables may contribute decomposed or filthy material to the finished
product. Be alert for use of low quality or salvage raw materials. Check
bags, bales, cases and other types of raw material containers to determine
signs of abnormal conditions, indicating presence of filthy, putrid or
decomposed items. Check any indication of gnawed or otherwise damaged
containers, to ascertain if material is violative. Be alert to contamination
of raw materials by infested or contaminated railroad cars or other carriers.
Document by photographs, exhibits or sketches any instances where insanitary
storage or handling conditions exist.
Food Chemicals Codex - Any substance used in foods
must be food-grade quality. FDA regards the applicable specifications
in the current edition of the publication "Food Chemicals Codex" as establishing
food-grade unless FDA publishes other specifications in the Federal Register.
Determine whether firm is aware of this publication and whether or not
they comply.
534 - EQUIPMENT AND UTENSILS
By arriving before processing begins, you are able to evaluate conditions
and practices not otherwise observable before plant start-up. This includes
adequacy of clean-up, where and how equipment is stored while not in
use, how hand sanitizing solutions and food batches are prepared and
if personnel sanitize their hands and equipment before beginning work.
Dirty or improperly cleaned equipment and utensils may be the focal
point for filth or bacterial contamination of the finished product. Examine
all equipment for suitability and accessibility for cleaning. Determine
if equipment is constructed or covered to protect contents from dust
and environmental contamination. Open inspection ports to check inside
only when this can be done safely. Notice whether inspection ports have
been painted over or permanently sealed.
Observe the firm's filtering systems and evaluate the cleaning methods
(or replacement intervals of disposable filters) and schedules. Check
types of filters used. There have been instances where firms have relied
on household furnace type filters.
Check the sanitary condition of all machinery. Determine if equipment
is cleaned prior to each use and the method of cleaning. If the firm
rents or leases equipment on a short-term basis, report prior cleaning
procedures. Equipment may have been used for pesticides, chemicals, drugs,
etc., prior to being installed and could therefore be a source of cross-contamination.
Inspect conveyor belts for build-up of residual materials and pockets
of residue in corners and under belts. Look in inspection ports and hard-to-reach
places inside, around, underneath, and behind equipment and machinery
for evidence of filth, insects, and/or rodent contamination. Chutes and
conveyor ducts may appear satisfactory, but a rap on them with the heel
of your hand or a rubber mallet may dislodge static material, which can
be examined. See IOM
427.06 for procedure on taking In-line Sample Subs.
Determine how brushes, scrapers, brooms, and other items used during
processing or on product contact surfaces are cleaned, sanitized and
stored. Evaluate the effectiveness of the practices observed.
Be alert for improper placement or inadequately protected mercury switches,
mercury thermometers, or electric bulbs. Breakage of these could spray
mercury and glass particles onto materials or into processing machinery.
If firm is using U.V. lamps for bacteria control, check if it has and
uses any method or meters to check the strength of U.V. emissions. If
so, obtain methods, procedures, type equipment used, and schedule for
replacement of weak U.V. bulbs.
In plants where chlorine solution is piped, check on type of pipe used.
Fiberglass reinforced epoxy pipe has been observed to erode inside through
the action of the chlorine solution. This poses a threat of contamination
from exposed glass fibers. Pipes made with polyester resin do not deteriorate
from this solution.
Observe sanitizing practices throughout the plant and evaluate their
effectiveness, degree of supervision exercised, strength, time, and methods
of use of sanitizing agents. Determine the use, or absence of, sanitizing
solutions both for sanitizing equipment and utensils as well as for hand
dipping. If chlorine is used, 50 ppm - 200 ppm should be used for equipment
and utensils, while a 100 ppm will suffice for hand dipping solutions.
Sanitizing solutions rapidly lose strength with the addition of organic
material. The strength of the solution should be checked several times
during the inspection.
535 - MANUFACTURING PROCESS
Where helpful to describe equipment and processes, draw flow plans or
diagrams to show movement of materials through the plant. Generally a
brief description of each step in the process is sufficient. List all
quality control activities for each step in the process and identify
Critical Control Points. Provide a full description when necessary to
describe and document objectionable conditions, or where the assignment
specifically requests it.
Observe whether hands and equipment are washed or sanitized after contact
with unsanitized surfaces. For example:
Be alert for optimum moisture, time and temperature conditions conducive
to bacterial growth.
In industries where scrap portions of the product are re-used or re-worked
into the process (e.g., candy and macaroni products), observe the methods
used in the re-working and evaluate from a bacteriological standpoint.
Re-working procedures such as soaking of macaroni or noodle scrap to
soften or hand kneading of scrap material offers an excellent seeding
medium for bacteria.
When a product is processed in a manner which destroys micro-organisms,
note whether there are any routes of recontamination from the "raw" to
the processed product (e.g. dusts, common equipment, hands, flies, etc.).
535.01 - Ingredient Handling
Observe the method of adding ingredients to the process. Filth may be
added into the process stream from dust, rodent excreta pellets, debris,
etc. adhering to the surface of ingredient containers. Evaluate the effectiveness
of cleaning and inspectional operations performed on the materials prior
to or while adding to the process. Determine specific trimming or sorting
operations on low quality or questionable material. Observe and report
any significant lags during the process or between completion of final
process and final shipping. For example, excessive delay between packing
and freezing may be a factor in production of a violative product.
535.02 - Formulas
The Act does not specifically require management to furnish formula
information except for human drugs, restricted devices and infant formulas.
Nonetheless, they should be requested especially when necessary to document
violations of standards, labeling, or color and food additives. Management
may provide the qualitative formula but refuse the quantitative formula.
If formula information is refused, attempt to reconstruct formula by
observing:
Any refusal to furnish requested information is reported in your EIR
under the refusal heading.
535.03 - Food Additives
Refer to the food additives program in the CPGM (Chapter 9) for instructions
on conducting establishment inspections of firms manufacturing food additive
chemicals. Information is also available in DFI's "Guide to the Inspection
of Manufacturers of Miscellaneous Food Products - Volume 2.
When making food plant inspections direct your evaluation of food additives
only to those instances of significant violation or gross misuse.
Routine inspectional coverage will be directed primarily to the following
two types of additives:
Because of special problems, exclude the following additives from coverage
during routine inspections:
The Food Additives Status List (FASL) contains an alphabetical listing
of substances, which may be added directly to foods or feeds and their
status under the Food Additives Amendment and Food Standards. In addition,
a few unauthorized or illegal substances are included. See IOM
Appendix A.
You may encounter substances not included in the Food Additives Status
List (FASL). Such substances will include:
Give primary attention to unauthorized substances. Document and calculate
levels of restricted-use additives in finished food only where gross
misuse or program violations are suspected as follows:
535.04 - Color Additives
Evaluate the status of all colors observed during each food establishment
inspection by using the Color Additives Status List. The list provides
the current status and use limitations of most colors likely to be found
in food, drug, device, or cosmetic establishments. See IOM
Appendix A.
Stocks of delisted and uncertified colors may be found in the possession
of manufacturers where there is no evidence of misuse. Advise the firm
of the status of these colors. If management wishes to voluntarily destroy
such colors, witness the destruction and include the facts in your EIR.
If the firm declines to destroy the colors, determine what disposition
is planned, e.g., use in non-food products.
Where decertified or restricted-use colors are used in manufacturing
food, drug, device, or cosmetics products, proceed as follows:
535.05 - Quality Control
The objective of quality control is to ensure the maintenance of proper
standards in manufactured goods, especially by periodic random inspection
of the product. Your inspection should determine if the firm's quality
control system accomplishes its intended purpose. Establish responsibility
for specific operations in the control system. Determine which controls
are critical for the safety of the finished product.
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Become familiar
with any applicable Compliance Policy Guide (