Norbrook Laboratories, Ltd.February 7, 2020

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

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Record Details

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.

Company: Norbrook Laboratories, Ltd.
Inspection Date: February 7, 2020
Product Type: Veterinary
Office: Center for Veterinary Medicine
People: Renee S Blosser
Roger F. Zabinski (Investigator)

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ID · eb46450f-cab4-49b4-a96b-e0bf6ebae761