FDA 483 - Norbrook Laboratories Limited - March 29, 2024

Norbrook Laboratories Limited, an animal drug product manufacturer in Newry, United Kingdom, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate procedures to prevent microbiological contamination of sterile drug products, failures in out-of-specification (OOS) investigations, and incomplete batch production and control records. These issues indicate a lack of robust quality control and aseptic processing practices.