FDA WARNING_LETTER - All American Pharmaceuticals - August 06, 2010

On August 5 and 6, 2010, the FDA inspected a firm at 2376 Main Street, Billings, Montana, and found serious violations of Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements (21 CFR Part 111). These violations cause the firm's dietary supplement products to be 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 (21 CFR 111.205(a))**: The firm's "bill of materials" lacked specifications for the manufacturing process and controls, and did not include all required elements under 21 CFR 111.210. The firm's August 13, 2010, response was inadequate, lacking documentation of master manufacturing records. 2. **Failure to include mandatory elements in batch production records (BPR) (21 CFR 111.260)**: * BPRs lacked reconciliation of label discrepancies (21 CFR 111.260(k)(1)), specifically for AAEFX ZMA 90 capsules, batch ticket #9753. The firm's response was insufficient, not addressing missing information or providing written reconciliation instructions. * BPR