FDA WARNING_LETTER - Bayer AG - January 20, 2017

The FDA inspected Bayer Pharma AG's Leverkusen facility from January 12-20, 2017, identifying significant CGMP violations, rendering their drug products adulterated.

Violations include: 1. **Inadequate Equipment Cleaning (21 CFR 211.67(b)):** Observed drug residue on exterior surfaces of non-dedicated equipment, leading to confirmed cross-contamination of a contract manufactured drug product, resulting in a recall. White residues were also found in "clean" manufacturing equipment, with cleaning procedures lacking provisions for these areas. Bayer's response was inadequate, failing to fully assess U.S.-shipped products or reevaluate cleaning for other non-dedicated equipment. 2. **Insufficient Investigation of Discrepancies (21 CFR 211.192):** Investigations into leaking product complaints lacked root cause determination, failed to address supplier-identified defects, and did not include retain sample examination or review of past complaints. Bayer's response lacked sufficient improvements to investigation systems. 3. **Inadequate Quality Control Unit (21 CFR 211.22(a) and (c)):** Discarded original personnel training records and automated visual inspection machine parameters were observed. Bayer's quality unit did not ensure proper record retention or reassess training effectiveness. The FDA clarified that setting parameters for automated inspection machines is a CGMP activity. 4. **Incomplete