FDA EIR - Biovet Joint Stock Company - October 23, 2015

An FDA inspection of Biovet Joint Stock Company in Peshtera, Bulgaria, conducted from October 19-23, 2015, revealed significant Good Manufacturing Practice (GMP) deficiencies. The inspection, covering quality, materials, production, and laboratory systems under compliance programs for Active Pharmaceutical Ingredients (APIs) and Animal Drugs Manufacturing (CP 7356.002F and CP 7371.005, referencing ICH Q7 and FD&C Act section 512(c)), resulted in a two-item FDA-483 form. Key violations included an inadequate stability program for finished animal drug products, such as Type-A Medicated Articles. The program used abbreviated testing intervals and failed to include lots exhibiting borderline analytical results, particularly those showing a tendency to decrease in potency or having consistently high microbial counts, ensuring product quality throughout the established shelf-life. Additionally, the Quality Control Unit lacked robust procedures to ensure chromatographic data integrity. This was evidenced by allowing unlimited manual peak integrations without proper justification, documentation, or tracking of changes. The integration parameters were not consistently recorded, preventing verification of result accuracy. The firm's Executive Director received the FDA-483 and committed to submitting a written response within fifteen working days. The Agency indicated further review of the cited observations, requiring Biovet to implement comprehensive corrective actions to comply with regulatory standards.