FDA 483 - Norbrook Laboratories, Ltd. - February 07, 2020

Norbrook Laboratories, Ltd. in Newry, United Kingdom, was cited for significant deficiencies in its animal drug product manufacturing operations. The inspection revealed widespread issues including a failure to follow stability testing programs, inadequate data integrity controls, poorly drafted and inconsistent written procedures, and insufficient component verification. Additionally, the facility showed poor maintenance and cleanliness, indicating a systemic lack of adherence to good manufacturing practices.