The United States Food and Drug Administration warned Vietnamese seafood exporter Ba Hai Company Ltd. about “serious deviations” from food safety requirements at the facility of its U.S. importer.
Tuy Hoa City, Vietnam-baed Ba Hai is a major processor and exporter of frozen tuna, swimming crabs and other seafood.
In late March, the FDA warned Ba Hai that its HACCP plan for scombroid species of fish contains “serious deviations” from seafood HACCP requirements, and said its frozen scombroid species of fish are adulterated.
The warning stems from FDA’s October inspection of Crystal Cove Seafood Corporation in Floral Park, New York, where the HACCP violations were found.
Ba Hai should keep its product “out of commerce until the cause of the deviation is corrected at the receiving, preserve…and pre-chilled critical control points to control scombrotoxin formation,” FDA said in the warning letter.
If Ba Hai’s response inadequate, the FDA said it may take further action, including refusing to allow the fish to be imported into the U.S.
Separately, the FDA recently warned Safe Harbour Seafood in Bon Secour, Alabama, about food safety violations.
“Your fishery products are adulterated, because they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” FDA said in its letter to Safe Harbour.
FDA said that Safe Harbour did not monitor every lot of fresh shrimp received to ensure that sulfites were not used at the “receiving” critical control point. “Your response provided the corrective action of including the statement on future fresh shrimp invoices and to obtain a completed….from each supplier of fresh shrimp. You should provide evidence showing the full implementation of this corrective action when fresh shrimp are received,” the agency wrote.
In addition, Safe Harbour did not ensure that not follow monitoring procedure for every lot of fresh whole fish (parasite carriers) sold to secondary processors.
“We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product and/or enjoin your firm from operating,” FDA wrote.
In an email, Crystal Cove Seafood Corporation, which imports frozen yellowfin tuna from Ba Hai, said the HACCP violation had been blown out of proportion by the FDA.
The company's email said:
On 11 and 13 October, 2016, FDA Consumer Safety Officers visited our premises in Floral Park, NY, to conduct an inspection of our facility and HACCP records. As an importer of frozen seafood products, we were asked to furnish HACCP documentation for a number of frozen tuna imports from the past year. Accordingly, we supplied all of the necessary documentation.
Upon examination of these documents, by the aforementioned consumer safety officers, the following observation was made: “You do not have an adequate affirmative step for the import of frozen tuna products packed by Ba Hai Joint Stock Company, Vietnam. Your record of the foreign packer’s HACCP plan did not list the significant hazards of allergens and Clostridium botulinum toxin formation.”
As a result of these observations, we immediately contacted our overseas supplier, Ba Hai Joint Stock Company, Vietnam, and requested the immediate review and revision of their HACCP plan, specifically addressing the listing of the significant hazards of allergens and Clostridium botulinum toxin formation. Shortly thereafter, we received a revised copy of their HACCP plan, addressing these points. Crystal Cove Seafood then supplied all of the revised documentation and corrective actions to the FDA.
On 8 December, 2016, we received a letter from Mr. William M. Rennells, of the U.S. FDA, confirming receipt of our response and corrective actions taken, to the inspectional observations made while at our office in October.
On 21 March, 2017, U.S. FDA issued a warning letter to Ba Hai Company Limited, regarding the “three significant deviations” of their HACCP plan. This warning letter was received by Ba Hai and they replied within the specified time period, explaining that they had retained the services of a consultant, reviewed and had re-written their HACCP hazard analysis, HACCP plan and records, to address the three significant deviations in accordance with the FDA Fish and Fishery Products Hazards and Controls Guidance – Fourth Edition. FDA is currently in the process of reviewing the submitted paperwork and revised HACCP records from Ba Hai Company.
We would like to point out that while FDA had discovered these issues pertaining to Ba Hai’s HACCP plan, at no time were their shipments rejected or detained for Clostridium botulinum toxin formation. In fact, Ba Hai has had a clean FDA record since 2014.
Crystal Cove Seafood takes food safety very seriously and will continue to ensure that the seafood supplied to its customers have been produced in facilities that comply with the HACCP Regulation 21 Code of Federal Regulations Parts 123 and 1240. “Procedures for the Safe Processing and Importing of Fish and Fishery Products.” These regulations require the application of Hazard Analysis and Critical Control Point (HACCP) evaluation principles to the processing of all domestic and imported seafood. The principles include:
(1) Conducting a hazard analysis of the seafood processing to determine if there is a significant likelihood that a food safety hazard may occur.
(2) Writing and implementing a HACCP plan if a significant hazard is identified.
(3) Monitoring eight key areas of sanitation regardless of whether a HACCP plan is necessary in order that conditions and practices conform to Good Manufacturing Practices (GMP).
Crystal Cove Seafood Corporation only imports products from facilities that provide documentation to verify their compliance with HACCP regulations.
