FDA WARNING_LETTER - My Habitat Brands LLC - October 21, 2020

The FDA issued a Warning Letter to My Habitat Brands, LLC following remote Foreign Supplier Verification Program (FSVP) inspections conducted from October 9-21, 2020, and previously on August 7, 2018. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandate importers perform risk-based activities to verify imported food meets U.S. food safety standards.

The company was found not in compliance, specifically failing to develop, maintain, and follow an FSVP for imported products including chocolate bar and chocolate dairy mix from (b)(4) and botanas puffed snack from (b)(4). These significant violations were noted on Form FDA 483a during both inspections.

My Habitat Brands' responses, including an email citing COVID-19 and submission of certificates (Food Safety System Certificate 22000, Health Certificate, Halal certificate) from one foreign supplier, were deemed inadequate as they lacked review documentation or explanation of their application to the FSVP program. No documents were provided for the other supplier.

The FDA warned that failure to promptly correct these violations could lead to refusal of admission for imported food products under Section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation