The U.S. Food and Drug Administration (FDA) issued a warning letter to Jin Han International, Inc., d/b/a Pacific Foods Co., after a facility inspection revealed “serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123)”.
According to the letter, the company failed to implement the requisite controls to ensure that their imported fish and fishery products “are not injurious to health or have not been processed under insanitary conditions,” as specifically set out in 21 CFR 123.12 (requirements for imported fish and fishery products).
The company has fifteen (15) days to respond to the warning letter with a detailed Corrective Action Plan (CAP) that outlines the specific measures being taken to correct these violations. To be effective, the CAP should include, at a minimum: (a) a written HACCP plan which addresses all potential species-related and process-related hazards; (b) importer verification records; and (c) all other records that document the performance and results of the company’s affirmative steps in correcting all existent violations as well as a timeline for when such corrective measures will be completed.
It is critical that Jin Han International submit a timely and effective response to the FDA, otherwise their food facility registration number may be suspended, as authorized under the Food Safety Modernization Act (FSMA). Under FSMA Section 102 the FDA may suspend the registration of a facility if FDA determines that food manufactured, processed, packed, received, or held by a facility has reasonable probability of causing serious adverse health consequences or death to humans or animals, and the facility:
- Created, caused or was otherwise responsible for such reasonable probability; or
- Knew of or had reason to know of such reasonable probability AND packed, received or held such food.
When a food facility registration is suspended, no person shall import or export food into the United States, offer to import or export food into the United States, or otherwise introduce food into interstate or intrastate commerce in the United States from such facility. Accordingly, until the Suspension Order is vacated and the facility’s registration is reinstated, neither the company nor any individual from the company may introduce food from the facility into interstate or intrastate commerce in the United States. This prohibition includes food produced, processed, packed, received, or held at the facility before the Suspension Order was issued but that is under the food facility’s control at the time.
If your company has received a Warning Letter from the FDA, or you have questions about FDA’s regulation of food facilities, our seasoned FDA attorneys can assist you. To speak with Ann Marie Gaitan, the chair of our FDA practice group today call 305.443.8900 or e-mail her at firstname.lastname@example.org.