FDA WARNING_LETTER - Dinamix Distribution, LLC. - June 28, 2019

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection at Dinamix Distribution, LLC on June 28, 2019, to assess compliance with section 805 of the Federal Food, Drug and Cosmetic Act and 21 CFR part 1 subpart L. The inspection revealed that the firm was not in compliance with FSVP requirements for imported products including mayonnaise, tomatoes-spice flavored drink, and punch flavored soft drinks. Specifically, Dinamix Distribution, LLC failed to develop an FSVP for these foods as mandated by the regulations. This constitutes a significant violation, indicating a fundamental lapse in ensuring imported foods meet U.S. food safety standards. The firm's August 8, 2019, response to the FDA 483a did not address this critical deficiency. The FDA requires prompt corrective action, including the development and implementation of compliant FSVPs. A written response, with supporting documentation, is due within fifteen working days. Failure to comply may result in refusal of admission for the affected products under section 801(a)(3) of the FD&C Act, potentially leading to detention without physical examination (DWPE) under Import Alert #99-41. Importing food without a compliant FSVP is also prohibited under section 301(zz) of the FD&C Act.