FDA WARNING_LETTER - Meditco, Inc. D.B.A. Phoenicia Specialty Foods - November 15, 2023

On February 27, 2024, the FDA issued a Warning Letter to Meditco, Inc. D.B.A. Phoenicia Specialty Foods following a Foreign Supplier Verification Program (FSVP) inspection conducted from November 8-15, 2023. This was the fourth inspection since June 2020. The inspection revealed the company is not in compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L, as they failed to develop, maintain, and follow an FSVP for any imported foods, including chickpeas, falafel spices, and rose syrup.

The FDA acknowledged the company's December 6, 2023, response stating they are hiring a consultant to develop an FSVP within 6-8 months, but deemed it inadequate due to a lack of supporting documentation. The letter emphasizes that failure to adequately address these violations may result in refusal of admission for imported food under Section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under Section 301(zz). Meditco, Inc. must respond in writing within fifteen working days, detailing corrective actions with supporting documentation.