FDA WARNING_LETTER - Prime Line Distributors, Inc. - February 12, 2020

On April 9, 2020, the FDA issued a Warning Letter to Prime Line Distributors Inc. following a Foreign Supplier Verification Program (FSVP) inspection on February 12, 2020, and a previous inspection on August 28, 2017. 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 ensure imported food meets U.S. food safety standards.

The primary violation identified was the failure to develop, maintain, and follow an FSVP for imported food products, including hazelnut paste from (b)(4), and Gran Padano and Parmigiano Reggiano cheeses from (b)(4). This constitutes a significant violation of Section 805 of the FD&C Act.

Prime Line Distributors Inc. received Form FDA 483a, FSVP Observations, after both inspections. The company's February 26, 2020, response stated they were working with a consultant to develop an FSVP plan within 60 days and obtained a letter of guarantee for hazelnut paste. However, the FDA found the response inadequate due to a lack of detail on the FSVP's scope. The company also claimed to no longer import Gran Padano or Parmigiano Reggiano from (b)(4), but shipping records