FDA 483 - Norbrook Laboratories, Ltd. - April 18, 2019

Norbrook Laboratories, Ltd. in Newry, United Kingdom, was inspected and received a Form 483 with five observations. The inspection revealed significant issues in quality control, including inadequate investigations into sterility failures and rejected batches, and a data integrity breach. Additionally, the firm failed to follow stability testing protocols, submit a timely Field Alert Report, and maintain adequate written procedures for production controls and visual inspector qualifications.