Norbrook Laboratories LimitedOctober 15, 2021

FDA 483 - Norbrook Laboratories Limited - October 15, 2021

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Record Details

Norbrook Laboratories Limited, an animal drug product manufacturer in Newry, United Kingdom, was cited for significant quality control deficiencies. The inspection revealed incomplete investigations into microbial and particulate out-of-specification results, lacking proper Quality Assurance approval and corrective actions. Additionally, equipment design issues led to drug products being exposed to substandard air quality during manufacturing.

Company: Norbrook Laboratories Limited
Inspection Date: October 15, 2021
Product Type: Veterinary
Office: Office of Biological Products Operations - Division I
People: Roger F. Zabinski (Investigator)
Jennifer L. Huntington

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ID · d60018ac-987e-4070-a0f8-42e4c82bd6e5