Jones Affiliated Inc. – FDA Warning Letter, Jun 22, 2022

The FDA issued a Warning Letter to Jones Affiliated Inc. on August 23, 2022, following Foreign Supplier Verification Program (FSVP) inspections conducted from June 7-22, 2022, and previously on July 18, 2019. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L.

The primary violation identified was the failure to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). This significant violation renders the firm non-compliant with section 805 of the FD&C Act. A Form FDA 483a, FSVP Observations, was issued on June 22, 2022, to which no response has been received.

Additionally, the FDA determined that the firm's facility at 17202 Marquardt Ave., Cerritos, CA, is subject to food facility registration requirements under section 415 of the FD&C Act and 21 CFR part 1, subpart H. As of the letter date, the facility remains unregistered, which is a prohibited act under section 301(dd) of the FD&C Act.

The FDA requires the facility to register within 30 working days. Failure to adequately