FDA WARNING_LETTER - ZULAND DISTRIBUTOR CORP - July 08, 2022

The FDA issued a Warning Letter to Zuland Distributor Corp following Foreign Supplier Verification Program (FSVP) inspections on June 28, July 8, 2022, and February 11, 2021. The inspections assessed compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The primary violation identified was the firm's failure to develop, maintain, and follow an FSVP for any imported foods, including "covered produce" as defined in 21 CFR 112.3. This violates 21 CFR part 1.502(a) and section 805 of the FD&C Act. For covered produce, the FSVP must demonstrate that suppliers meet U.S. food safety standards, specifically those under section 419 of the FD&C Act and 21 CFR part 112 (Standards for Produce Safety).

The firm received a Form FDA 483a on July 8, 2022, but no response has been received. Failure to adequately address these violations may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, potentially leading to detention without physical examination (DWPE) under Import Alert #99-41. Additionally, importing food without a compliant FSVP is prohibited under section 3