FDA WARNING_LETTER - Vibrant Enterprise Llc - August 04, 2020

The FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Vibrant Enterprise, LLC, from July 14 to August 4, 2020, following a previous inspection on September 13, 2018. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandates importers to perform risk-based activities to verify that imported food meets U.S. food safety standards.

The FDA found that Vibrant Enterprise, LLC, was not in compliance with FSVP requirements for imported food products, including but not limited to Tamarind Paste, Chatpata Chaat Makhana Pops, Kesar Mango Pulp, and Sarson Ka Saag. Specifically, the company failed to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). Additionally, for thermally processed low-acid canned foods like Sarson Ka Saag, the company did not verify and document production in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1).

The company's August 13, 2020, response to the FDA 483a observations was deemed inadequate as it lacked timeframes for completion, written procedures, or documentation of corrective actions or developed FSVPs