FDA WARNING_LETTER - Leimax, Corp. - April 19, 2022

On April 5-19, 2022, the FDA conducted an inspection of Leimax, Corp. at 179 Saw Mill River Rd #B, Yonkers, NY 10701, to assess compliance with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1, subpart L) under section 805 of the FD&C Act. Previous inspections occurred on June 18, 2018, and March 4, 2020.

The inspection revealed a significant violation: Leimax, Corp. failed to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). This non-compliance also violates section 805 of the FD&C Act. A Form FDA 483a FSVP Observations was issued on April 19, 2022, to which no response has been received.

If Leimax, Corp. 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 (21 CFR 1.512(b)(1)(i)). Even as a very small importer, compliance with 21 CFR 1.502, 1.5