FDA 483 - Norbrook Laboratories Limited - March 29, 2024

During an inspection from March 18-29, 2024, the FDA issued a Form 483 to Norbrook Laboratories Limited, an animal drug product manufacturer in Newry, United Kingdom. The inspection revealed significant deviations from current Good Manufacturing Practices (cGMP) for sterile drug products.

Key issues included a lack of established or followed procedures to prevent microbiological contamination during sterile operations. Inspectors observed operators keeping aseptic processing isolator doors open on multiple sides simultaneously without supporting airflow studies, and exhibited poor aseptic technique, such as touching critical surfaces and blocking critical airflow. Additionally, interventions during media fills were incompletely documented.

The firm's quality control system also had deficiencies, specifically regarding the review of discrepancies and out-of-specification (OOS) results. Observations noted the invalidation of OOS results without identified root causes, a failure to investigate temperature excursions during product shipments, inadequate root cause analysis in OOS investigations, and delays in initiating these investigations. Furthermore, batch production records were deficient, lacking documentation of critical sterility sampling times, which could impact sample representativeness.

In response to these findings, Norbrook Laboratories is required to submit a comprehensive plan of corrective and preventive actions to the FDA, detailing how they will address each observation and ensure compliance with regulatory standards.