FDA WARNING_LETTER - Pasha Food Distribution USA, Inc. - March 18, 2020

On May 18, 2020, the FDA issued a Warning Letter to Pasha Food Distribution USA, Inc. following Foreign Supplier Verification Program (FSVP) inspections on September 12, 2018, and March 18, 2020, at their Chatsworth, California facility. The inspections revealed non-compliance with Section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) and 21 CFR Part 1 Subpart L, concerning FSVP requirements.

Specifically, Pasha Food Distribution USA, Inc. failed to establish FSVPs for imported roasted eggplant from (b)(4), and dried sumac and tahini from (b)(4). Although the company claimed to be a very small importer, they did not provide supporting documentation as required by 21 CFR 1.500. Furthermore, even if classified as a very small importer, their submitted supplier letters from (b)(4) and (b)(4) did not adequately address compliance with relevant U.S. food safety standards or explain how they met FSVP requirements under 21 CFR 1.512(b)(3)(i).

Additionally, the FDA determined that the facility at 9813 Independence Avenue, Chatsworth, California, was subject to food facility registration requirements under Section 415 of the FD&C Act and 21 CFR Part 1,