FDA EIR - Biovet AD - July 26, 2013

The FDA conducted a pre-approval and routine cGMP inspection of Biovet Joint Stock Company in Peshtera, Bulgaria, from July 22 to July 26, 2013. This inspection evaluated the manufacturing of Active Pharmaceutical Ingredients (APIs) for both human and veterinary use, guided by FDA compliance programs and ICH Q7 Good Manufacturing Practice.The inspection revealed six significant deficiencies, documented in a Form FDA 483. Key violations included the absence of stability-indicating methods for an API, inconsistencies in sample preparation between release and stability testing, and insufficient data to confirm temperature control during a critical API process. The agency also noted uncontrolled laboratory data sheets, raising concerns about data integrity, and inadequate identification of testing equipment like balances and pH meters in production and laboratory records. Additionally, analytical data recording was flawed, specifically regarding imprecise reference standard weights and the lack of unique identification for replicate samples.Biovet was reminded of its responsibility to manufacture APIs in accordance with the FD&C Act and was required to submit a written response within 15 business days addressing all observations with supporting evidence. While Biovet made voluntary corrections to certain facility deficiencies during the inspection, which were verified, other proposed corrective actions for data control and equipment identification were unverified at the time of the report.