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

Source: https://www.keypedia.com/records/warning_letter/leimax-corp/834667b8-99f3-447b-9e3a-097c5583614d

> FDA WARNING_LETTER for Leimax, Corp. on April 19, 2022. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Leimax, Corp.
- Inspection Date: 2022-04-19
- Product Type: Food
- Office Name: Division of Northeast Imports 
- Summary: 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

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/joseph-s-tomao/e4e38a9e-7143-485f-ae8e-8f7106eeb87b)

Company: https://www.keypedia.com/companies/leimax-corp/df18e51f-6c10-498e-93f8-c8e308a3353a

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94