If you have or are importing from a foreign facility, it is important to know that FDA can issue 483s through a Foreign Remote Regulatory Assessment, and follow up with a Warning Letter if the facility does not respond to the 483, as was the case with a seafood processor in Indonesia. FDA found the facility to have serious violations of the Seafood HACCP regulations, including:
- The Hazard Analysis was not complete since the hazard of pathogen growth, including Salmonella, which can pose risks in this situation, was not addressed.
- The critical limits included in the HACCP Plan were not deemed adequate to prevent the formation of histamine, which can cause serious symptoms within minutes or hours of consumption. Histamine is a heat-stable toxic metabolite produced by certain bacteria found in some fish species that can be formed if the fish are not properly refrigerated.
- The monitoring procedures listed in the HACCP plan were not implemented properly and consistently.
- The corrective actions included in the HACCP plan were deemed not adequate to ensure that the affected product did not enter commerce and that the deviation would be corrected.
Regardless of where a facility is located, it is subject to U.S. food safety requirements and FDA inspection if the food is intended for consumption in the U.S. As this Warning Letter shows, FDA does not need to be onsite to cite a facility, or to continue with enforcement action if steps are not taken to correct the issues.
