FDA WARNING_LETTER - Barohup Inc. - August 21, 2023

On August 28, 2024, the FDA issued a Warning Letter to Barohup Inc. following Foreign Supplier Verification Program (FSVP) inspections on January 17, February 22, and July 21-August 21, 2023. The inspections found significant violations of section 805 of the FD&C Act and 21 CFR part 1, subpart L, concerning imported human and animal food.

Key violations include: 1. Failure to develop, maintain, and follow an FSVP for most imported foods (21 CFR 1.502(a)). A submitted response regarding Korean pears lacked documentation of a qualified individual's evaluation and foreign supplier approval. 2. Failure to establish and follow written procedures for importing foods only from approved foreign suppliers (21 CFR 1.506(a)(1)). Barohup Inc. continued importing enoki mushrooms from a supplier despite determining it was "not safe to import" from them. 3. Failure to promptly reevaluate foreign supplier performance and food risk upon becoming aware of new information (21 CFR 1.505(c)(1)). This occurred after a positive Listeria monocytogenes result for enoki mushrooms. 4. Failure to promptly investigate and modify the FSVP after determining a foreign supplier does not comply with U.S. food safety standards or produces adulter