FDA WARNING_LETTER - Maspeth Wholesale Corp - March 04, 2020

On May 14, 2020, the FDA issued a Warning Letter to Maspeth Wholesale Corp. following a Foreign Supplier Verification Program (FSVP) inspection on March 4, 2020, with a previous inspection on July 25, 2018. The inspection aimed to assess compliance with section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) and 21 CFR part 1 subpart L, which mandates importers perform risk-based activities to verify imported food meets U.S. safety standards.

The inspection revealed significant violations: Maspeth Wholesale Corp. failed to develop, maintain, and follow an FSVP for chili powder imported from their foreign supplier (b)(4), or for any other imported food products. This directly violates 21 CFR 1.502(a) and section 805 of the FD&C Act. An FDA Form 483a, FSVP Observations, was issued on March 4, 2020, but no response was received.

The FDA warns that failure to promptly correct these violations may lead to further action, including refusal of admission for imported food products under section 801(a)(3) of the FD&C Act, and placement on detention without physical examination (DWPE) via Import Alert # 99-41. Importing food without a compliant FSVP