FDA Draft Guidance released December 2017– FDA Foreign Food Facility Inspection

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance which updates the FDA’s interpretation of “refusal of inspection.” Previously, the FDA requires food facilities receiving notice of FDA inspection to confirm acceptance of the inspection within 5 business days, but has now stated that the FDA expects a confirmation within 24 hours. Failure to confirm within 24 hours may be considered refusal of inspection, resulting in delays of the food facility’s future food shipments to the United States. Also, any attempts to limit or condition the inspection in any way may be deemed a refusal of inspection, resulting in similar disruptions to the facilities shipments to the US.

What are the Consequences of Being Deemed a Refusal?

Facilities that refuse inspection are placed under Import Alert 99-32. Consequently, their food shipments face refusal of admission at the port of U.S. entry. Additionally, the food facility’s FDA registration may be suspended.

How Can I Prevent Being Deemed a Refusal?

The FDA’s guidance underscores importance of understanding FDA’s expectations for the inspection process and utilizing a reliable U.S. Agent. A facility’s failure to reply to an inspection notice before the stated deadline or to unreasonably deny the inspection will be interpreted as a refusal to permit USFDA to conduct the inspection. A failure to accommodate reasonable inspection can be used by USFDA as evidence of failing to comply with FDA regulations. Based on this evidence, FDA may refuse entry of a facility’s products into the U.S. until FDA is able to verify, through inspection, that the products meet applicable U.S. requirements. During an FDA inspection, food facilities should be cooperative with the FDA inspector. Any attempts to interfere with or delay the inspection, may constitute refusal. Facilities should accommodate the FDA inspector’s requests and allow a full observation of daily operations.

What can I expect during an FDA inspection?

The inspection of food facilities is typically scheduled for 3-5 days and conducted according to the Preventive Controls for Human Food regulations. The new FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food regulations went into effect in 2016 with a staggered implementation date. Currently, a firm qualifies for a Preventive Controls based inspection depending on total annual sales. If total annual sales for a firm are greater than $1 million USD; FDA will inspect based on the new regulations. Aside from a routine inspection including manufacturing operations and Current Good Manufacturing Practices (CGMP’s), a Preventive Controls based inspection also includes an in-depth review of your Food Safety Plan and will be conducted and assessed based on 21 CFR, Part 117 “CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD”.


Below are the following links regarding FMSA Preventive Controls inspections and the new 21 CFR Part 117 regulations for your review:

“Guidance for Industry: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide” Link

21 CFR Part 117: “CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD” Link

Links to FDA site: https://www.fda.gov/Food/ComplianceEnforcement/Inspections/ucm196386.htm