FDA WARNING_LETTER - Hameln Pharmaceuticals Gmbh - June 14, 2012

On December 17, 2012, the FDA issued a Warning Letter to Hameln Pharmaceuticals GmbH following an inspection from June 4-14, 2012, which identified significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211) for finished pharmaceuticals. These violations render their drug products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Personnel Training (21 CFR 211.25(a)):** Employees lacked adequate training, evidenced by an inability to accurately record microbial counts and failure to follow procedures for sterile filling operations (e.g., glove changes, handling dropped objects, personnel monitoring, sample acquisition). The firm's response, citing re-training, was deemed insufficient as it didn't explain the system's failure to detect these lapses. 2. **Aseptic Processing Procedures (21 CFR 211.113(b)):** The firm failed to establish or follow appropriate written procedures to prevent microbiological contamination. Smoke study videos were inadequate to evaluate Class A airflow quality, lacking sufficient evidence to support conclusions about unidirectional flow and particle removal. The FDA requested additional evidence or repetition of studies. 3. **Environmental Monitoring (21 CFR 211.42(c)(