FDA WARNING_LETTER - H & A Walters Fulfillment Center - March 15, 2019

The FDA conducted an inspection of a dietary supplement manufacturing facility in Gainesville, GA, from March 11-15, 2019, revealing significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). These violations render the manufactured dietary supplements adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to prepare and follow written master manufacturing records for each unique formulation and batch size (21 CFR 111.205(a)). 2. Failure to establish specifications for various stages of the manufacturing process, including components, in-process materials, labels, packaging, and finished products (21 CFR 111.70(a)-(e), (g)). This also includes a lack of required testing and documentation for specifications. 3. Incomplete batch production records, missing information such as maintenance dates, component identity/weight, actual yield, monitoring results, finished product documentation, and packaging/labeling details (21 CFR 111.255(b), 111.260). 4. Improper storage of components, dietary supplements, and labels, leading to potential mix-up or contamination (21 CFR 111.455(c)). 5. Failure to identify and quarantine returned dietary