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

Source: https://www.globalkeysolutions.net/records/483/norbrook-laboratories-ltd/eb46450f-cab4-49b4-a96b-e0bf6ebae761

> FDA 483 for Norbrook Laboratories, Ltd. on February 07, 2020. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Norbrook Laboratories, Ltd.
- Inspection Date: 2020-02-07
- Product Type: veterinary
- Office Name: Center for Veterinary Medicine
- Summary: 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.

## Related Officers

- [Renee S Blosser](https://www.globalkeysolutions.net/people/renee-s-blosser/9d974c8f-0324-4657-ae51-f2d2d1df919a)
- [Investigator](https://www.globalkeysolutions.net/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

Company: https://www.globalkeysolutions.net/companies/norbrook-laboratories-ltd/19709c98-6040-4d06-8c7f-a416cc4b7f91

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4