GOLDEN NATURAL PRODUCTS – FDA Warning Letter, Jul 13, 2023
On October 5, 2023, the FDA issued a Warning Letter to Mr. Gregori Akbashev of Golden Natural Products following a Foreign Supplier Verification Program (FSVP) inspection conducted from July 11-13, 2023, and a previous inspection from January 5-12, 2022. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L.
The FDA found significant violations, specifically that the firm failed to develop, maintain, and follow an FSVP for imported foods, including Dried Apricots Subkhani, Dried Cherry Plums, and Noodles. This violates 21 CFR Part 1.502(a). The firm also failed to respond to the Form FDA 483a FSVP Observations issued on July 13, 2023.
Even if the firm qualifies as a "very small importer" under 21 CFR 1.500 and chooses to comply with modified requirements in 21 CFR 1.512, it must document this status per 21 CFR 1.512(b)(1)(i) and still comply with 21 CFR 1.502, 1.503, and 1.509. Additionally, for each imported food, written assurance from the
ID · 40a38efc-d193-4d97-a4c9-b97f2ee3cec0
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