FDA WARNING_LETTER - Flax & More Corporation - October 29, 2025

Flax & More Corporation, located in Cutler Bay, Florida, received an FDA Warning Letter following an inspection conducted from October 21 through 29, 2025. The agency identified significant violations of the Federal Food, Drug, and Cosmetic Act regarding Current Good Manufacturing Practice (CGMP) for dietary supplements. These violations cause the company’s products to be considered adulterated under federal law.

The primary issues cited involve failures in manufacturing hygiene and quality control. Specifically, the FDA found that manufacturing equipment was not properly maintained, with residue found in the seams of a hopper, creating risks of cross-contamination—particularly regarding allergens like wheat bran. Furthermore, the company failed to establish complete quality specifications for its finished products, lacking standards for identity and purity. The inspection also revealed that the firm"s master manufacturing records were missing essential details, including expected production yields and standardized procedures for sampling and testing.

While the company submitted a response in November 2025, the FDA determined it was inadequate because it lacked documented evidence of corrective actions, such as updated procedures or proof of equipment improvements. Flax & More Corporation is required to provide a written response within 15 working days detailing the specific steps taken to address these violations and prevent their recurrence. Failure to correct these issues may result in legal action, including product seizures or injunctions.