FDA WARNING_LETTER - Genesis Herb Company LLC - July 06, 2012

The FDA inspected a dietary supplement manufacturing facility in Canton, OH, from May 24 to July 6, 2012, revealing significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). Products including Seizure, Relax, Formula ARTH, Disintegrate, Gout, Plantain, and Colloidal Silver were deemed adulterated and misbranded.

Key violations include: 1. Failure to establish and follow written procedures for quality control operations, including material review, disposition decisions, and reprocessing approval (21 CFR 111.103), and failure to identify quality control personnel (21 CFR 111.12(b)). 2. Failure to prepare and follow written master manufacturing records for each unique formulation and batch size (21 CFR 111.205(a)). 3. Failure to implement production and process controls and establish specifications for manufacturing processes, components (e.g., distilled water, Milk Thistle), and finished products (21 CFR 111.55, 21 CFR 111.70). 4. Failure to establish and follow written procedures for holding and distributing operations, and maintain associated records (21 CFR 111.453, 21 CFR 111.475(a)). 5. Batch production records lacked required