The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not made visible to the public until weeks or months after they are sent. Business owners have 15 days to respond to warning letters from the FDA. Warning letters are often only issued after a company has been given months or years to resolve problems.
The US Food and Drug Administration (FDA) recently sent warning letters to two companies, Choo’s Enterprises Ltd. and J. Moniz Company Inc., for significant violations of U.S. food safety regulations relating to 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 from March 4 to 6, revealed violations of FDA regulations for emergency authorization review and acidified foods.
The FDA noted that the company had failed to submit planned 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 US. In addition, the FDA found that Choo’s Enterprises personnel involved in food processing were not supervised by someone trained in acidification, a critical requirement to ensure product safety.
Choo’s Enterprises responded in April, indicating that they were in consultation with a litigation authority and planned to have their staff undergo relevant training. However, the FDA found the response inadequate and warned that if the company does not address these violations, their products could be denied entry into the U.S. and subject to detention without a physical examination.
The full warning letter can be viewed here.
J. Moniz Company Inc.
Falls River, MA
The FDA has sent a warning letter to J. Moniz Company Inc., a seafood importer based in Falls River, MA, following an inspection that found serious violations of the Hazard Analysis and Critical Control Point (HACCP) regulations Point) for seafood. The letter, dated August 7, outlines concerns about the company’s import practices for fish and fishery products, particularly raw, fresh, chilled skipjack bonito and sardines from Portugal.
The inspection, conducted on June 24, revealed that J. Moniz Company Inc. failed to implement the required “affirmative step” to ensure that imported fish and fishery products are processed in accordance with FDA regulations. The FDA cited violations related to the import of striped bonito and sardines from a Portuguese supplier. Without these positive steps, the FDA determined that these products were adulterated because they were prepared, packaged, or stored under conditions that could be harmful to health.
The FDA explained that without proper verification that the seafood products have been processed under conditions equivalent to U.S. standards, the products may be subject to denial 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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