FDA WARNING_LETTER - The Muscadine Group, LLC - September 05, 2012

On September 4-5, 2012, the FDA inspected Muscadine Grape Seeds Antioxidant Vegetable Capsules' facility in Pine Level, NC. The inspection and subsequent website review revealed the product was promoted with therapeutic claims, classifying it as an unapproved new drug under section 201(g)(1)(B) of the Act, violating sections 505(a) and 502(f)(1). The company had been previously warned about similar violations in November 2007.

Additionally, the product was deemed an adulterated dietary supplement due to serious Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111). Deficiencies included: 1. Failure to prepare and follow adequate Master Manufacturing Records (MMR) (21 CFR 111.205, 111.210(h)). 2. Failure to establish and verify component and finished product specifications (21 CFR 111.70, 111.75, 111.303). 3. Inadequate production and process controls (21 CFR 111.55). 4. Failure to identify qualified quality control personnel with distinct responsibilities (21 CFR 111.12(b)). 5. Incomplete batch production records (21 CFR 111.255(b