BHARAT RATAN LLC DBA MDM Super Market – FDA Warning Letter, Apr 5, 2022
On August 22, 2022, the FDA issued a Warning Letter to Bharat Ratan LLC following a Foreign Supplier Verification Program (FSVP) inspection on April 5, 2022, and previous inspections on December 20, 2019, and September 14, 2020. The inspection revealed significant violations of section 805 of the FD&C Act and 21 CFR part 1, subpart L, as the firm failed to develop, maintain, and follow an FSVP for any imported foods. A Form FDA 483a was issued on April 14, 2022, to which no response was received.
The letter also noted that even if Bharat Ratan LLC qualifies as a "very small importer" under 21 CFR 1.500, they must still comply with FSVP requirements, including annual documentation of their status and obtaining biennial written assurances from foreign suppliers regarding compliance with U.S. food safety standards (21 CFR 1.512(b)(1)(i) and 1.512(b)(3)).
Furthermore, the firm's facility at 19030 116th Ave. SE Renton, WA 98058-7159, is subject to the registration requirement under section 415 of the FD&C
ID · 64ae3d85-557a-4631-9521-acf52104e8d6
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