FDA 483 - Tairgi Tread-Lia Baile Na Sceilge Teoranta (Ballinskelligs Veterinary Products) - June 17, 2022

An FDA inspection of Tairgi Tread-Lia Baile Na Sceilge Teoranta (Ballinskelligs Veterinary Products), a veterinary drug manufacturer, revealed significant deficiencies across its laboratory and production systems. Observations included inadequate testing of bulk drug batches, lack of written procedures for quality control and electronic records, and failures in equipment calibration and reserve sample examination. These issues indicate a need for comprehensive improvements in the firm's quality management and manufacturing practices.