Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3003132211.
Violations1
Issue DateFeb 27, 2024
Product TypeFood & Beverages
StatusOpen
Letter Details
Firm
Meditco, Inc. D.B.A. Phoenicia Specialty Foods
Location
Mr. Raffi Tcholakian
Operations Manager
Meditco, Inc. D.B.A. Phoenicia Specialty Foods
12141 Westheimer Rd.
Houston , TX 77077
United States
FEI Number
3003132211
Country
United States
Issue Date
February 27, 2024
Issuing Office
Division of Southwest Imports
Product Type
Food & Beverages
Status
Open
Summary
Meditco, Inc., a Houston-based food and beverage importer, failed to comply with Foreign Supplier Verification Program (FSVP) requirements under the Federal Food, Drug, and Cosmetic Act during an FDA inspection conducted November 8-15, 2023. The company did not perform required risk-based verification activities to ensure that imported human and animal foods met applicable U.S. food safety standards, representing significant violations of 21 CFR Part 1, Subpart L. This was a recurring compliance issue, as the company had been inspected previously in 2020, 2022, and again in 2023, with the firm committing to develop a comprehensive FSVP program within 6-8 months from its December 2023 response.
Meditco, Inc. D.B.A. Phoenicia Specialty Foods FDA Warning Letter, February 27, 2024