Inspections, Compliance, Enforcement, and Criminal Investigations
SUBCHAPTER 6.4 - FIELD EXAMINATION
6.4 - FIELD EXAMINATION
6.4.1 - GENERAL
6.4.2 - FIELD EXAMINATION SCHEDULE
6.4.3 - FIELD EXAMINATIONS - FOODS
126.96.36.199 - Food Sanitation
188.8.131.52 - Pesticides, Industrial Chemicals, Aflatoxins, & Toxic Elements
184.108.40.206 - Food and Color Additives
220.127.116.11 - Nutrition and Food Allergen Labeling and Consumer Protection Act (FALCPA)
18.104.22.168 - Food Economics (On Consumer Size Containers only)
22.214.171.124 - Cosmetics
6.4.4 - FIELD EXAMINATION - DRUGS
126.96.36.199 - Labeling
188.8.131.52 - Contamination
184.108.40.206 - Samples
220.127.116.11 - Special Instructions
6.4.5 - FIELD EXAMINATIONS - DEVICES
6.4.6 - FIELD EXAMINATIONS - BIOLOGICS
6.4.7 - FIELD EXAMINATIONS - VETERINARY PRODUCTS
18.104.22.168 - Veterinary Drugs
22.214.171.124 - Devices
126.96.36.199 - Animal Feed
188.8.131.52 - Animal Grooming Aids
184.108.40.206 - Biologicals
6.4.8 - FIELD EXAMINATIONS RADIOLOGICAL HEALTH
6.4.9 - FIELD EXAMINATIONS- TOBACCO PRODUCTS
A field examination is an on-the-spot examination or field test performed on a product to support a specific decision. It may be conducted on products discharged from vessels on to the wharves (piers), pier sheds, and other locations; products in trucks, trains, freezers, and containers, etc., at border entry points; or on products set aside for FDA examination. Some compliance program guidance manuals do not address field examinations. Nevertheless, field examinations are appropriate for certain problems and/or commodities and should be conducted.
A field examination involves actual physical examination of the product for such things as:
- Confirming quantity present corresponds to quantity declared on shipping documents,
- In transit or storage damage,
- Inadequate storage temperature conditions,
- Rodent or insect activity,
- Lead in ceramic ware (Quick Color Test – QCT and Rapid Abrasion Test - RAT),
- Odors uncharacteristic for the product or of spoilage,
- Non-permitted food and/or color additives, and
- General label compliance
When conducting a field examination, compare documents provided by filer/importer, to what is physically available during your inspection.
A field examination does not have the same level of confidence as a laboratory examination. Consequently, more rigorous standards of acceptance are applied than those used for formal regulatory levels. For example, if the formal action guideline for whole insects is 10 per 100 gm in product X, you may sample product X when your field examination shows only one or two insects per 100 gm. The decision to sample is, to some degree, left to your discretion. In most instances, it should be based on findings significantly lower than specified by the formal guideline.
A field examination begins when the physical examination is started. Do not include, as reported Field Examination time, the time to locate the lot or travel time. Time spent in locating the lot is reported as import investigation.
See IOM 220.127.116.11 for suggestions on what to do when conducting a field examination and the firm responsible for the products invites individuals who are not directly employed by the firm to observe the examination.
A Field Examination should include a physical examination of a minimum of five containers (cases, cans, bags, etc.) of a product, or as directed by Compliance Program Guidance Manuals, specific product examination schedules (e.g., LACF), or other guidance.
When you conduct any field examination, in addition to specific items discussed in the following sections, be alert for any over labeling where a product name or identity may have been changed; product without mandatory English labeling; changes in expiration date or lot numbers; product quantity differences; product integrity; country of origin or similar questionable practices. If you encounter any of these items, document your findings and discuss the appropriate action with your Supervisor.
See IOM 18.104.22.168.2 for guidance on performing reconciliation examinations during import field examinations.
Microbiological - field examinations cannot be used for suspected microbiological contamination.
Filth and Foreign Objects - field examine only those product/container combinations in which you can physically view and examine the product, e.g., products which can be probed, products in see-through containers, etc. See 5.1.5, et al for some specific guidance on performing field examinations.
Low acid and other Canned Foods - See IOM Chapter 4 SAMPLE SCHEDULE CHART 2.
Decomposition in Non-sealed Foods - This can include organoleptic examination for fish, seafood, frozen eggs, etc.
Field examinations cannot be performed for most of these materials, except for metals in dinnerware and the side -seam solders of cans.
NOTE: Districts should use commercial versions of the Quick Color Test (QCT) and the Rapid Abrasion Test for lead, e.g. Lead Check Swabs. While conducting field examination of dinnerware and food cans to determine if follow-up sampling is required. The testing scheme for dinnerware can be found in CPGM 7304.019B. Specific information regarding the techniques of testing dinnerware and can side seam solder can be found in Lab Information Bulletin (LIB) 4127 and LIB 4041, respectively on the Division of Field Science (DFS) intranet site.
Perform a visual examination of the container and a label review for the mandatory labeling requirements. For example, determine if a color additive is declared for a product which appears coloring has been added. Determine if a preservative declaration includes its function; for example, "Sodium Benzoate as a preservative."
The use of a color additive must conform with the requirements stated in the color additive's listing regulation. These requirements are outlined in the "Color Additive Status List" and the "Summary of Color Additives Listed for Use in the United States in Food, Drugs, Cosmetics, and Medical Devices." These lists provide the current status and use limitations of color additives permitted in food, drug, cosmetic, and medical device products.
Requirements for declaring color additives on food labels are given in 21 CFR 101.22(k). Color additives subject to certification may be declared by the names listed in 21 CFR parts 74 and 82 or by abbreviated names that omit "FD&C" and "No." The term "Lake" must be included in the names of color additive lakes. FD&C Yellow No. 5 is specifically required to be declared on food labels under 21 CFR 101.22(k) and 21 CFR 74.705. Color additives not subject to certification may be declared by the names listed in 21 CFR part 73 or in general terms such as "Artificial Color," "Artificial Color Added," or "Color Added."
NOTE: Label examinations of products to determine whether there is a declaration of certain food and/or color additives are reported as import investigations.
The only valid field examination which can be performed for this type of problem is a label examination for the mandatory labeling requirements. See the "Guide to Nutritional Labeling and Education Act (NLEA) Requirements" document. Also see the Office of Nutrition, Labeling and Dietary Supplements (ONLDS), website (http://www.fda.gov/Food/LabelingNutrition/LabelClaims/default.htm) for the most up-to-date information regarding claims in labeling. Also, see CPGM 7321.005 to determine enforcement priorities for food labeling violations.
Label Examination - Review labels for all aspects of the labeling requirements.
Net weight - See IOM 22.214.171.124
Food Standards - The only valid field examination which can be performed for Food Standards is a label examination for the mandatory labeling requirements of a particular Food Standard.
NOTE: Label examinations of products to determine if the labeling meets the mandatory labeling requirements for a particular Food Standard must be reported as an Import Investigation.
Valid cosmetic field examinations include a reconciliation examination for security purposes and/or a label examination for the mandatory labeling requirements. The most important labeling considerations are:
- Ingredient Labeling (21 CFR 701.3),
- Prohibited ingredients (21 CFR 700.11 through 700.27 and 250.250),
- Non-permitted color additives (see Color Additives Status Lists)
- Warning Statements (21 CFR 740.11, 740.12, 740.17, and 740.19),
- Cautionary/Other Required Statements (Coal tar hair dyes not displaying the caution statement can be considered adulterated - FD&C Act sec. 601(a), caution statement for the color additive lead acetate -21 CFR 73.2396, required label information for the color additive bismuth citrate - 73.2110, and required label information for the color additive henna - 73.2190)
- Tamper Resistant Packaging Requirements (21 CFR 700.25)
For further questions contact the Office of Cosmetics and Colors, (240) 402-1130.
NOTE: Label examinations of products to determine whether their labeling declares certain ingredients must be reported as an Import Investigation.
When you conduct field examinations of drugs (bulk drugs and finished dosage forms) ensure you check:
- Labeling compliance (e.g., Reye Syndrome warning)
- Probable contamination
- Tamper Resistant Packaging Requirements
Bulk drugs and finished dosage forms should be evaluated for compliance with the Drug Listing Act, 21 CFR 207.40. Refer to the Drug Listing Compliance Program Guidance Manual.
Drugs should be examined for container integrity, e.g.: cracked vials, ampoules, bottles, etc.
A decision to collect samples for Drug Listing Act compliance evaluation should be made in accordance with the drug listing CPGM. The nature of samples to be taken from lots where the drug substance or finished product has been subjected to actual or suspected contamination should be decided on a case-by-case basis.
Field examinations may be made of drug lots to obtain information in determining the new drug status of a given shipment. Districts should contact the Division of New Drugs and Labeling Compliance, Import/Export International Drug Team, (HFD-319) for guidance.
Medical device field exams involve mostly label or labeling review. The label should include the name and business of the manufacturer, packer or distributor and product identity. Be aware of misdeclared devices, for example, TENS (transcutaneous electrical nerve stimulation) devices are often declared as therapeutic massagers but in fact should be declared as neurological therapeutic device. Products declared as destined for “veterinary use only” must include such a statement on the packaging and product. CAUTION: If the sealed packaging, such as an outer crate, of a medical device indicates that the manufacturer’s warranty will be violated should it be opened by someone other than a factory representative, DO NOT open the packaging. Consult with your supervisor regarding any further action. For further guidance for labeling provisions refer to 21 CFR Part 801.
Medical device field exams include electrode lead wires, patient cables, labeling, and physical damage. Lead wires and patient cable exams should conform to applicable standards set forth in 21CFR Part 898.
Field examination guidance documents issued by CDRH are found at Division of Import Operations and Policy intranet site.
During any field exam you may conduct of "sterile" devices offered for entry, which are destined for sterilization at a sterilizer, per 21 CFR 801.150: each pallet, carton, or other designated unit is conspicuously marked to show its non-sterile nature when it is introduced into and moving in interstate commerce, and while it is being held prior to sterilization. Following sterilization, and until such time as it is established that the device is sterile and can be released from quarantine, each pallet, carton, or other designated unit is conspicuously marked to show that it has not been released from quarantine, e.g., "sterilized--awaiting test results" or an equivalent designation. It is a common industry practice to manufacture and/or assemble, package, and fully label a device as sterile at one establishment and then ship such device in interstate commerce to another establishment or to a contract sterilizer for sterilization. FDA will not initiate regulatory action against the device as misbranded or adulterated when the non-sterile device is labeled sterile if the lot is marked appropriately as noted previously. This cite also requires a written agreement between the foreign firm and the importer of record. Specifically, there is in effect a written agreement which: (i) Contains the names and post office addresses of the firms involved and is signed by the person authorizing such shipment and the operator or person in charge of the establishment receiving the devices for sterilization.(ii) Provides instructions for maintaining proper records or otherwise accounting for the number of units in each shipment to insure that the number of units shipped is the same as the number received and sterilized.(iii) Acknowledges that the device is nonsterile and is being shipped for further processing, and(iv) States in detail the sterilization process, the gaseous mixture or other media, the equipment, and the testing method or quality controls to be used by the contract sterilizer to assure that the device will be brought into full compliance with the Federal Food, Drug, and Cosmetic Act.
Review RPM Chapter 9-3 "Importation of Biologics" and the Import Alert regarding biologics prior to conducting any field examinations of biological products.
In general, products controlled by Center for Biologics Evaluation and Research (CBER) do not require field examination, because they are licensed under Section 351 of the PHS Act. In addition, lot release procedures pursuant to 21 CFR 610.2 apply to many products, such as vaccines.
Products imported under Investigational New Drug (IND) Applications are also monitored, but due to the small volumes involved, no specific guidance is necessary.
Shipments of biologics which are not licensed, or are not directly related to an active IND should be examined for:
- Intended use
Contact CBER/OC/Division of Case Management (HFM-610) for guidance.
Contact the CVM Division of Compliance (HFV-230), the Post-Market Compliance Team, with general questions on the importation of veterinary products. You should be aware of various Import Alerts, Compliance Policy Guides or Guidance Documents as they affect individual import situations. See the CVM website for additional information or notifications on current import situations
Field examinations of veterinary drugs are visual examinations to determine potential misbranding or adulteration. This may include examination for:
- Container Integrity
- Labeling Compliance
- Product adulteration
Dosage form drugs must be examined to determine if they are new animal drugs. If the products are new animal drugs, you need to determine if an approved NADA/ANADA exists or if there is a valid INAD exemption in place. You should consult with CVM's Division of Compliance (HFV-230) regarding the status of imported veterinary products (240-276-9200).
Bulk New Animal Drug substances and Active Pharmaceutical Ingredients (APIs) may be legally imported only if destined to the holder of an approved NADA or INAD exemption. You will need to consult with the Center for the status of particular drugs.
Entries of prescription animal drugs for use by the consumers (laymen) must be examined for labeling content, consignee (name and address) and to determine if a valid prescription/order exists from an appropriately licensed veterinarian. CVM (240-276-9200) should have records of any exemptions or permission granted for personal imports.
Devices intended for animals do not require premarket approval. However, they are still subject to examinations for misbranding violations. Animal devices must bear adequate directions for use and label claims must not be false or misleading. You should consult with CVM for guidance (240-276-9200).
Animal feeds and feed components, including pet foods should be examined for conformance with all applicable and appropriate food labeling requirements, drug claims, food additive violations and use of banned or objectionable ingredients as well as filth and foreign objects. You should consult with CVM on individual issues and to determine specific requirements (240-276-9200).
'Cosmetics' for animals are referred to as "animal grooming aids". While CVM does not actively pursue enforcement actions with animal grooming aids, the products are expected to be safe, effective and properly labeled. The labels and labeling of any incoming animal grooming aids are subject to examination and review for potential instances of misbranding. Consult with CVM for appropriate guidance. The Division of Compliance (240-276-9200) can answer regulatory and enforcement questions.
CVM does regulate animal biologic products. They are considered as drugs. However, CVM does not regulate animal vaccines. The vaccines are regulated by USDA/APHIS.
Field Examinations for imported electronic products consist of reviewing the Entry Documents and FDA-2877, Declaration for Products Subject to Radiation Control Standards, to determine if they are properly completed and accurate. This applies to each shipment of electronic products for which performance standards exist. Performance standards, covering ionizing, optical, microwave and acoustic radiation-emitting products, are specified in 21 CFR 1020 through 1050.
For electronic products, physical samples may only be collected on specific assignment. DTR/DER recommendations are to be submitted when the Field Examination indicates the product may not be in compliance and detention is recommended.
Import coverage for radiation emitting products is provided for in a CDRH Compliance Program Guidance Manual. Do not collect physical samples except on specific assignment, or with concurrence of CDRH.
Contact the CTP Office of Compliance and Enforcement, Enforcement and Manufacturing Group, with general questions on the importation of tobacco products. See the CTP website for additional guidance, compliance, and regulatory information for tobacco products.