The U.S. Food and Drug Administration (FDA) has issued warning letters to two different companies warning them that they are committing “serious” violations of health and safety standards set by the FDA for seafood processing and sale.
The letters cited American seafood processor Roundman’s Smokehouse and Thai seafood company Southeast Asian Packaging and Canning for violations of the Hazard Analysis and Critical Control Point (HACCP) regulations, which led to products produced by both companies that “may have been rendered injurious to health.”
For Roundman’s, the FDA on 30 May cited six “serious” violations of HACCP regulations, including:
- An incomplete HACCP plan that does not include declarations of allergans.
- A HACCP plan and plant procedures that do not adequately protect its smoked salmon and smoked albacore products from pathogens or toxins
- Unsanitary production conditions
- A HACCP plan that does not account for controlling growth of Staphylococcus aureus
- Multiple violations regarding the company’s ability to control the formation of scombrotoxin (histamine) toxins.
For Southeast Asian, the letter, dated 9 June, cited four key violations, including:
- A HACCP plan that does not account for controlling growth of Staphylococcus aureus
- Multiple violations regarding the company’s ability to control the formation of scombrotoxin (histamine) toxins.
The FDA noted Roundman’s responding in prior communications with descriptions of a plan to control its violations, and the FDA said it would be returning to follow up.
For both companies, the FDA threatened additional action if the violations were not corrected. For Southeast Asian, the FDA said this could include forbidding the import of its products to the United States. For Roundman’s, the FDA said action could include seizing products or shutting the company’s plant down.
