FDA warns food companies for violations in acidified foods and seafood imports

The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

The U.S. Food and Drug Administration (FDA) recently issued warning letters to two companies, Choo’s Enterprises Ltd. and J. Moniz Company Inc., for significant violations of U.S. food safety regulations concerning acidified foods and seafood imports, respectively.

Choo’s Enterprises Ltd.
Saint Michael, Barbados

On June 3, the FDA sent a warning letter to Choo’s Enterprises Ltd. in Barbados following an inspection of their low-acid and acidified food facility. The inspection, which took place March 4-6, revealed violations of the FDA’s Emergency Permit Control and Acidified Foods regulations.

The FDA noted that the company had failed to submit scheduled process information for several of its acidified food products, such as Mauby Syrup and Ginger Beer Syrup, as required by law. Without this information, the products cannot be legally offered for sale in the U.S. Additionally, the FDA found that Choo’s Enterprises’ staff involved in food processing were not supervised by someone trained in acidification, a critical requirement for ensuring product safety.

Choo’s Enterprises responded in April, indicating they were consulting with a process authority and planning to have their staff take a relevant training course. However, the FDA found the response insufficient and warned that if the company does not address these violations, their products could be refused entry into the U.S. and subjected to detention without physical examination.

The full warning letter can be viewed here.

J. Moniz Company Inc.
Falls River, MA

The FDA has issued a warning letter to J. Moniz Company Inc., a seafood importer based in Falls River, MA, following an inspection that revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation. The letter, dated Aug. 7, outlines concerns regarding the company’s importation practices for fish and fishery products, specifically raw, fresh, chilled skipjack bonito and sardines from Portugal.

The inspection, conducted on June 24, found that J. Moniz Company Inc. had failed to implement the required “affirmative step” to ensure that the imported fish and fishery products are processed in accordance with FDA regulations. The FDA cited violations related to the importation of skipjack bonito and sardines from a Portuguese supplier. Without these affirmative steps, the FDA determined that these products were adulterated, having been prepared, packed, or held under conditions that could render them injurious to health.

The FDA explained that without proper verification that the fish products were processed under conditions equivalent to U.S. standards, the products may be subject to refusal of entry into the United States under the Federal Food, Drug, and Cosmetic Act.

The full warning letter can be viewed here.

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