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

Source: https://www.globalkeysolutions.net/records/483/norbrook-laboratories-ltd/13828f63-b414-4307-adf6-a557aaf5d7ca

> 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, 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.

## Related Documents

- [483 - 2019-04-18](https://www.globalkeysolutions.net/records/483/norbrook-laboratories-ltd/79685dcf-f586-4d64-9312-ec4926b22834)

## 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/108ea27a-3213-4a32-8623-e412641c38aa

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