My Habitat Brands LLC Warning Letter Details

Summary

My Habitat Brands LLC failed to establish Foreign Supplier Verification Programs (FSVP) for imported food products, including chocolate bars, chocolate dairy mix, and botanas puffed snacks, in violation of Section 805 of the Federal Food, Drug and Cosmetic Act and 21 CFR Part 1 Subpart L. The company was inspected twice—initially on August 7, 2018, and again via remote inspection from October 9-21, 2020—with FDA investigators documenting the same FSVP compliance deficiencies on both occasions through Form FDA 483a observations. Despite previous notice of violations, the company had not implemented adequate risk-based verification activities to ensure imported food met applicable U.S. food safety standards.