FDA WARNING_LETTER - DASADA GROUP LLC - June 26, 2024
On August 1, 2024, the FDA issued a Warning Letter to Dasada Group LLC following Foreign Supplier Verification Program (FSVP) inspections on December 6, 2022, and June 26, 2024. The inspections, conducted at 2602 Kelley St. Ste. B, Houston, Texas, found the company non-compliant with section 805 of the FD&C Act and 21 CFR part 1, subpart L.
The primary violation is the failure to develop, maintain, and follow an FSVP for imported foods, including fresh produce, as required by 21 CFR 1.502(a). The FDA noted that if the imported fresh produce is "covered produce," the FSVP must ensure suppliers comply with produce safety standards (21 CFR part 112). A Form FDA 483a FSVP Observations was issued on June 26, 2024, to which no response has been received.
Additionally, Dasada Group LLC is subject to food facility registration requirements under section 415 of the Act and 21 CFR Part 1, Subpart H. The company was advised of this during the inspection but has not registered. Failure to register is a prohibited act under section 301(dd) of the Act.
The FDA requires Dasada Group LLC to register its facility within
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