VUAB Pharma a.s. – FDA Warning Letter, Jun 13, 2014

On May 27, 2015, the FDA issued a Warning Letter to VUAB Pharma a.s. following an inspection from June 9-13, 2014, which identified significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs). These deviations render their human and veterinary APIs adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Investigation of Customer Complaints:** The firm failed to properly investigate and resolve quality-related customer complaints, specifically regarding microbial contamination (Clostridium sphenoides and Bacillus spp.). Their microbiological test methods were inadequate, and investigations did not identify root causes or extend to all potentially affected batches. Sampling procedures were also found deficient and not statistically justified. 2. **Failure to Control Data Integrity:** The firm did not retain complete raw data from testing, specifically HPLC chromatograms, due to unreadable backup discs since at least 2013. The HPLC system lacked access controls, an audit trail, and all laboratory employees shared a common login, raising concerns about data authenticity and reliability. This issue was also noted in a September 2008 FDA inspection.

The FDA found the firm's July 1, 2014, response, and subsequent correspondence, to lack sufficient corrective actions. Required corrective actions include an accelerated timeline for