FDA 483 - Bayer Healthcare Animal Health Inc - April 21, 2009

This FDA Form 483 details significant deficiencies at a pharmaceutical manufacturing facility. The primary issue, a repeat deficiency, is the Quality Unit's failure to monitor and implement Quality Systems, evidenced by 16 subsequent observations.

The firm failed to reject drug products not meeting specifications, including Thiamine HCL 200 mg Injection (lot 7060828) with particles, and multiple lots of Levothyroxine 0.5 mg and 0.8 mg tablets exhibiting appearance defects like "capping," "picking," spots, and disintegration. Investigations into discrepancies were inadequate, not extending to other affected batches or products. For instance, the Thiamine HCL investigation did not review other lots or manufacturing equipment, and a risk assessment was performed by unqualified personnel. Investigations into particulate failures in Sterile WFI, USP, used in all products, were also deficient. Complaint investigations for crumbling Levothyroxine tablets were not comprehensive or timely.

The facility lacks process validation for numerous Small Volume Parenteral, Oral Solution, and Large Volume Parenteral products, violating their own SOPs. Manufacturing equipment qualification was also found deficient. Deviations from procedures, such as incident investigation and Field Alert reporting, were not properly recorded or justified. Multiple Field Alert reports for serious issues like particulate matter and incorrect formulations were not filed within the required three business days.

Annual visual examinations of reserve samples for deterioration are not performed, and the procedure for these exams is inadequate, with untrained