FDA WARNING_LETTER - Gobwa Exotic Imports Inc. - July 21, 2022

The FDA conducted FSVP inspections of Gobwa Exotic Imports Inc. on July 5-21, 2022, and February 9-March 4, 2021, at 1127 Nostrand Ave., Brooklyn, NY. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L, concerning imported human and animal food safety.

The FDA found significant violations, indicating non-compliance with FSVP requirements for imported foods. A Form FDA 483a FSVP Observations was issued. The company's August 8, 2022, response was deemed inadequate due to a lack of specific documentation regarding actions taken to develop FSVPs, details on proposed audits (standards, integration into FSVPs, completion dates), and insufficient documentation for supplier evaluations and verification activities.

Key violations include: 1. Failure to develop, maintain, and follow an FSVP for imported fresh produce (covered produce), specifically demonstrating compliance with 21 CFR part 112 standards. 2. Failure to conduct a written hazard analysis for each imported food type or document review and assessment of foreign supplier hazard analyses, including verification that they were conducted by a qualified individual (21 CFR 1.504(a) and (d)). This applied to fresh bananas, soursop, and hot peppers.