FDA 483 - Norbrook Laboratories, Ltd. - February 07, 2020
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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.
ID · 13828f63-b414-4307-adf6-a557aaf5d7ca