FDA EIR - VUAB Pharma a.s. - June 13, 2014

An FDA inspection of VUAB Pharma a.s. in Roztoky, Czech Republic, conducted from June 9-13, 2014, identified significant deficiencies in their manufacturing of non-sterile active pharmaceutical ingredients (APIs). This comprehensive inspection, under the regulatory framework of CVM pre-approval and CDER cGMP for APIs supporting a New Animal Drug Application (NADA), revealed multiple issues. Key violations included an inadequate test method for microbiological contamination (Clostridium spp.), which failed to detect all strains, and complaint investigations for microbial contamination (Bacillus spp.) that were not sufficiently broad to assess other affected batches. Furthermore, out-of-trend analytical and microbiological results lacked proper investigation and timely corrective actions. Equipment deficiencies were noted, such as balances and scales not calibrated within their operational range and an HPLC instrument that lacked adequate qualification, passwords, audit trails, and data backup. Sampling plans for product release, stability, and reserve samples were found not to be representative, and retention samples were not visually inspected for deterioration. Mr. Jan Mengler, General Manager, was issued an FDA-483 and verbally committed to corrective actions. A written response outlining planned actions was received by the FDA on July 2, 2014. Immediate actions included modifying the Clostridium test method. The company also planned a full renovation of its Class D cleanroom by February 2015 to address facility-related concerns.