FDA 483 - Norbrook Laboratories Limited - October 15, 2021

Norbrook Laboratories Limited, an animal drug product manufacturer in Newry, United Kingdom, was cited for significant quality control deficiencies. The inspection revealed incomplete investigations into microbial and particulate out-of-specification results, lacking proper Quality Assurance approval and corrective actions. Additionally, equipment design issues led to drug products being exposed to substandard air quality during manufacturing.