FDA WARNING_LETTER - Global Biotechnologies, Inc. - March 16, 2012

On August 21, 2012, the FDA issued a Warning Letter to Global Biotechnologies, Inc. following an inspection from January 25 to March 16, 2012. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111) for dietary supplements, rendering their Glucanol and Lactopril products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act. The firm's March 30, 2012 response was deemed inadequate.

Key violations include: 1. **Failure to establish in-process specifications** for strength and composition in Master Manufacturing Records (MMRs), specifically for capsule weight (21 CFR 111.70(c)(1)). 2. **Failure to establish adequate component specifications** for identity, purity, strength, and composition of raw materials, such as gelatin capsules (21 CFR 111.70(b)). 3. **Failure to package and label as specified in the MMR**, evidenced by the lack of a written MMR for Glucanol dietary supplement packaging and labeling (21 CFR 111.415). 4. **Batch Production Records (BPRs) lacking complete information**, including equipment cleaning dates, unique component identifiers, component weights, actual/theoretical yields,