The U.S. Food and Drug Administration (FDA) has sent a warning letter to Stavis Seafoods over regulatory violations at its Boston, Massachusetts, U.S.A.-based facility.
A warning letter sent by the FDA said an inspection in February found “serious violations” of Hazard Analysis and Critical Control Point (HACCP) regulations. Specifically, 21 CFR 123.12 – which requires companies to have importer verifications by either obtaining products from a country with a memorandum of understanding or similar agreement with the FDA covering the products or have verification procedures in place qualifying to FDA standards and the company must maintain records on all of the steps followed under those regulations.
The FDA said Stavis did not have or had not implemented “an affirmative step” to ensure the products met those standards.
Stavis, in a statement to the Boston Business Journal, said the issue was an “administrative documentation matter and did not involve product safety, product quality, contamination, consumer health concerns, or any product recall.”
“The FDA's observation related to a documentation requirement associated with one supplier among the hundreds of suppliers with whom we conduct business,” Stavis told the Business Journal. “Specifically, the inspection identified that a required importer verification document was not current in our records. The requested documentation was promptly provided, and the updated records were provided to the FDA within 48 hours of the observation.”
The company said it fully cooperated throughout the process and that it hadn’t imported products from the supplier flagged by the FDA since October 2025.
