FDA scrutinizes import companies for regulatory compliance

Texas - The Food and Drug Administration (FDA) consistently enforces its regulatory responsibilities by issuing warning letters to organizations it identifies as potentially noncompliant with federal regulations.

These advisory notices often remain confidential for some time post-dispatch, and businesses are typically given a period of fifteen days to submit a formal reply. It's worth noting that the issuance of such warnings usually follows an extended period during which the organization has been given opportunities to address highlighted concerns.

Recently, Eco Food Distribution LLC, located in Schiller Park, Illinois, has come under the FDA's review for not implementing a Foreign Supplier Verification Program (FSVP) for the diverse international foods they import. An FDA warning letter from May 25 provided an in-depth account of an FSVP review carried out from February 28 to March 29.

The FDA's examination revealed that Eco Food Distribution LLC has not adhered to the stipulations present in FSVP guidelines. As a result, the FDA issued Form 483a, which lists critical violations that demand urgent action. Primary violations listed include:

• Lack of a consistent and properly managed FSVP, especially regarding foods imported from specific foreign vendors.
• Absence of required hazard analysis documentation for each food type imported. For example, the firm did not provide a hazard analysis for imported items like chocolate-covered gingerbread apples and carrot nectar.
• An inadequate approval process for foreign suppliers and missing documentation related to supplier evaluations, particularly concerning the mentioned food products.
• A clear oversight in conducting mandatory foreign supplier verification processes.

The complete warning letter can be accessed here.

In a similar vein, Moises Gardea, an importer based in Albuquerque, New Mexico, received a warning letter on June 12. This followed an FSVP inspection that took place between March 9 and March 24. The FDA's examination resulted in the issuance of Form 483a, which highlighted significant non-compliances.

The review indicated Moises Gardea's failure to develop and implement an FSVP for several food products, including different varieties of Asadero and Mennonite Cheese, sourced from anonymous foreign suppliers.

The complete warning letter can be accessed here.

The inspection found that FVD Produce did not have an FSVP in place for several fresh produce items, including fresh tomatoes, husk tomatoes, carrots, and various onions, imported from unknown foreign suppliers.

The complete warning letter can be accessed here.

Credit: U.S. Food and Drug Administration, Dallas Metro News