FDA EIR - Biovet AD - October 23, 2015

An FDA inspection of Biovet Joint Stock Company in Peshtera, Bulgaria, was conducted from October 19-23, 2015. Carried out under CDER work-plan and Compliance Programs for Active Pharmaceutical Ingredients and Animal Drug Manufacturing, the inspection identified several Good Manufacturing Practice (GMP) deficiencies, which were formally documented on an FDA Form 483. Main violations included a deficient stability program for finished animal drug products, which failed to gather sufficient data to monitor quality attributes across the established shelf-life. This program used abbreviated testing intervals and did not adequately address observed trends from annual product reviews, such as product content decreases or impurities and microbial counts consistently nearing specification limits. Additionally, the Quality Control Unit lacked robust procedures to ensure chromatographic data integrity, permitting unlimited manual peak integrations without proper justification or documentation of changes, which could compromise analytical accuracy. Issues were also noted regarding batch record reviews, retain sample documentation, and the proper management of equipment log-books and environmental monitoring records. Biovet's management acknowledged these observations and committed to providing a written response within fifteen working days for the Agency's review.