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

Norbrook Laboratories, Ltd. in Newry, United Kingdom, received a Form 483 for significant deficiencies in its animal drug product manufacturing. The inspection revealed failures in following stability testing programs, inadequate data integrity controls, and poor adherence to deviation reporting procedures. Additionally, the firm lacked properly drafted written procedures and maintained its facilities and equipment in an unclean state.