As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. 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) has issued warning letters to two companies for significant violations of the Foreign Supplier Verification Program (FSVP), which requires importers to ensure that food brought into the United States meets federal safety standards. The letters, sent to AH USA Group Inc. in California and Gonzar Produce LLC in Texas, highlight ongoing noncompliance despite previous inspections and opportunities to address issues.
AH USA Group Inc.
Commerce, CA
The FDA conducted an FSVP inspection of AH USA Group Inc., located in Commerce, CA, from Oct. 2-9, 2024, following an earlier inspection from Aug. 25-30, 2022. During the most recent visit, the agency determined that the company failed to develop, maintain, or follow an FSVP for the foods it imports, including dried mushrooms, preserved starberries, and rice vermicelli from foreign suppliers.
At the conclusion of the October inspection, FDA investigators provided the company with a Form FDA 483a outlining the violations. AH USA Group responded via email on Oct. 23, 2024, promising corrective actions such as requesting supplier information, taking an FSVP class, and noting that two suppliers provided certificates of analysis. However, the FDA found the response inadequate because of a lack of supporting documentation, and no further records have been submitted.
The agency also noted that the company had previously imported black fungus subject to a May 2023 recall because of Salmonella contamination. It no longer imports this product. The FDA emphasized that AH USA Group must conduct comprehensive hazard analyses — beyond just allergens — and implement supplier verification activities to comply with FSVP regulations.
The full warning letter can be found here.
Gonzar Produce LLC
McAllen, TX
Gonzar Produce LLC, located in McAllen, TX, underwent an FSVP inspection from Dec. 16-17, 2024, following a prior inspection on July 18-19, 2023. The FDA found that the company still had not developed or implemented an FSVP for its imported fresh produce, including fresh mangoes and guavas from foreign suppliers.
Investigators issued a Form FDA 483a at the end of the December inspection, but the company has not responded to date. The FDA pointed out that some of Gonzar Produce’s imports may be “covered produce” under the Produce Safety Rule, requiring verification that foreign suppliers meet U.S. safety standards. No documentation demonstrating compliance was provided.
Additionally, the FDA noted that Gonzar Produce’s facility is subject to food facility registration requirements under the FD&C Act, which the company has not fulfilled despite being advised during the inspection. Failure to register is a prohibited act that could lead to further enforcement.
The agency warned that continued noncompliance could result in the detention of the company’s imported products without physical examination and additional regulatory actions.
The full warning letter can be found here.
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