FDA WARNING_LETTER - Willing's Group, Inc. - September 29, 2010

On September 23-29, 2010, the FDA inspected Willing's Group, Inc. in Cherry Hill, NJ, a firm that packages and labels dietary supplements. The inspection revealed serious violations of Current Good Manufacturing Practices (CGMPs) for dietary supplements (21 CFR Part 111), rendering their products 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 (MMRs) for each unique formulation and batch size (21 CFR 111.205(a)). No MMRs were prepared. 2. Failure to prepare a batch production record for each batch of dietary supplement (21 CFR 111.255(a)). No batch production records were prepared. 3. Failure to establish and follow written procedures for packaging and labeling operations (21 CFR 111.403). No such procedures existed. 4. Failure to establish and follow written procedures for quality control operations, including material review, disposition decisions, and reprocessing (21 CFR 111.103). No written procedures for these functions were in place. 5. Failure to make and keep documentation of employee training, including date, type, and persons trained (21 CFR 111.14(b)(2