1. Upon Further Review: Preparing for and Handling an FDA Inspection
July 12, 2016
Daniel Dwyer
Kleinfeld, Kaplan and Becker, LLP

2. Inspection Federal Food, Drug, and Cosmetic Act (FDCA) § 704(a)
Present credentials
Written notice
Enter any establishment in which food is manufactured, processed, packed, or held; or vehicle
Interstate commerce
Inspect the establishment or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein
At reasonable times and within reasonable limits

3. § 414 Inspections
Inspection extends to all records and other information described in FDCA § 414:
FDCA § 414(a)(1): Food that FDA believes is adulterated and presents a threat of serious adverse health consequences or death to humans or animals
FDCA § 414(a)(2): FDA believes there is a reasonable probability that the use of or exposure to food will cause serious adverse health consequences or death to humans or animals

4. § 414 Inspections Written notice: FDA Form 482c Covers:
All records needed to determine whether food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals
All records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation
All records relating to any food likely to be affected in a similar manner
Except recipes, financial data, pricing data, personnel data, research data, or sales data (other than shipments)

5. Allergen Inspection
FDCA § 704a: FDA must conduct inspections consistent with the authority under FDCA § 704
Ensure reduction of cross- contact with residues of major food allergens that are not intentional ingredients; and
Ensure major food allergens are labeled

6. Inspection – Infant Formula
FDCA § 704(a)(3): FDA may access, copy and verify any records:
Bearing on whether the food meets infant formula nutritional requirements, or
Required to be maintained for infant formula

7. Inspection – Shipments
FDCA § 703:
FDA may access and copy shipping records upon written request
FDA may access and copy required food transportation records

8. Records Inspection Regulations
Low acid canned foods
Acidified foods
Seafood
Juice
Bottled water
Certain health claim regulations

9. FSMA Inspectional Authority
Hazard analysis & preventive control records (FDCA § 418)
Foreign Supplier Verification Program records (FDCA § 805)
Third-party auditor reports (non-consultative) (FDCA § 808(c)(3))
Designated “high-risk” food records (FSMA § 204(d))

10. Form FDA-483
FDCA § 704(b):
Upon completion of inspection FDA must provide a written report indicating:
Any filthy, putrid, or decomposed substance, or
Food prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth, or may have been rendered injurious to health

11. Inspectional Samples FDCA § 704(c): Receipt for samples taken
FDCA § 704(d): Results of analysis shall be furnished promptly to the owner, operator, or agent in charge

12. Food Safety Modernization Act (FSMA) Inspection Goals
FDCA § 421:
High-risk domestic establishments: once between 2011 & 2016, then every 3 years
Lower-risk domestic establishments: once between & 2018, then every 5 years
Foreign establishment: at least 600 by January 2012, double number annually for 5 years
Ports of Entry:
Risk-based allocation of inspection resources

13. Administrative Detention
FDCA § 304(h)
Authorized by 2002 Bioterrorism Act
Temporary adjunct to FDA’s seizure authority

14. Summary Guidelines Contact plant manager Check inspector’s credentials
1. Inspector arrives:
Contact plant manager
Check inspector’s credentials
Ask inspector to fill out facility’s sign-in sheet
Plant manager contacts Quality and Legal
2. Opening conference:
Establish conference room
Determine scope of inspection (e.g., routine, follow-up on recall, etc.)
Inform inspector of required safety procedures
Take notes

15. Summary Guidelines Plan tour based on scope of inspection
3. Inspection Tour:
Plan tour based on scope of inspection
Accompany inspector at all times
Respond to inquiries cooperatively, carefully and accurately
When questions arise, do not refuse to provide requested information, but contact Quality or Legal
If the inspector takes samples, environmental swabs, pictures or copies of documents, the facility should maintain similar information as part of its inspection record

16. Summary Guidelines 4. Closing conference: 5. Post-Inspection:
Do not sign documents without legal approval
Review inspectional observations carefully and ask questions to clarify
State that a written response will be provided
Make notes of any verbal inspectional observations
If a corrective action has already been made, request that it be documented in the inspector’s record
5. Post-Inspection:
Prepare written report immediately after the inspection
FDA-483 should be responded to within 15 working days
Obtain FDA’s Establishment Inspection Report (EIR)

17. Common Issues Photographs
Dow Chemical v. United States, 476 U.S (1986) (however, this case dealt with open-air views of a facility)
United States v. Acri Wholesale Grocery Co., 409 F. Supp. 529 (S.D. Iowa, 1976) (however, in this case, management did not object to photography)

18. Common Issues Internal audits Affidavits Timeliness of response
FDA will generally not request records of internal audits conducted under a written quality program
Affidavits
Timeliness of response
Answer questions truthfully and completely, so that the inspector has a correct understanding of the facts

19. Recent Observations Aggressive inspection, sampling, and follow up
Especially on food safety issues
Extensive foreign inspections
Detention at borders
Use of regulatory meetings

20. FDA Office of Criminal Investigations
Inspection authority may be augmented by warrants
Seeking criminal evidence, e.g., for –
Health fraud
Product tampering
Adulteration and/or misbranding of food
September 2015: Peanut Corp. of America executives sentenced to 28 and 20 years in prison