Sobh Import, Inc. Warning Letter Details

Summary

Sobh Import, Inc. was cited for failing to establish Foreign Supplier Verification Programs (FSVP) for food products including Lokum Biscuit, Sugar-Coated Pistachios, and Nougat with Cardamom imported into the United States, in violation of section 805 of the Federal Food, Drug and Cosmetic Act and 21 CFR part 1 subpart L. The company had no FSVPs in place for any of its imported food products despite two FDA inspections—an initial inspection in November 2018 and a follow-up remote inspection in March 2021—both of which resulted in FDA 483a observations. This marked a repeat violation, as the company had been previously notified of these deficiencies but failed to implement compliant procedures prior to the second inspection.