FDA WARNING_LETTER - Vita Pure Inc - September 23, 2010

On September 10-23, 2010, the FDA inspected Vita Pure, Inc., a dietary supplement manufacturer in Roselle, New Jersey. The inspection revealed serious violations of 21 CFR 111, Current Good Manufacturing Practice (CGMP) for dietary supplements, rendering products adulterated under section 402(g)(1) of the Federal Food, Drug and Cosmetic Act.

Key deficiencies include: 1. Failure to determine if finished product specifications for purity, strength, and composition were met for products like Calcium 600 W/ Vitamin D3 and Immpower (AHCC 500mg), as testing only occurred upon customer request (21 CFR 111.73, 111.75(c)). 2. Master Manufacturing Records (MMRs) lacked complete component lists, theoretical yields, packaging descriptions, representative labels, sampling procedures, and corrective action plans for Immpower and Calcium 600 W/ Vitamin D3 (21 CFR 111.210). 3. Failure to follow a written MMR for each unique formulation and batch size, with evidence of manual modification of batch sizes (21 CFR 111.205(a)). 4. Batch Production Records (BPRs) for Immpower and Calcium 600 W/ Vitamin D3 lacked identity of equipment used (