FDA WARNING_LETTER - Healthtex Distributors, Inc. - February 01, 2023

The FDA inspected a dietary supplement warehouse and distribution facility in Miami, Florida, from January 24 to February 1, 2023. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering the products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. Failure to establish and follow written procedures for quality control operations, including material review and disposition decisions (21 CFR 111.103, 21 CFR 111.113). The firm lacked any written quality control procedures and did not perform quality control operations for finished dietary supplements like Dr. Sana Cod Liver Oil and Dr. Sana Orange Blossom Flower Water. 2. Failure to establish and follow written procedures for holding and distributing operations (21 CFR 111.453). The firm admitted to not having these procedures, and a submitted procedure did not address all requirements, such as appropriate storage conditions based on product label temperatures (21 CFR 111.455(a)). 3. Failure to identify individuals responsible for quality control operations (21 CFR 111.12(b)).

Additionally, Dr. Sana Cod Liver Oil and Dr. Sana Orange Blossom Flower Water products were found to be mis