# FDA 483 - Norbrook Laboratories, Ltd. - April 18, 2019

Source: https://www.globalkeysolutions.net/records/483/norbrook-laboratories-ltd/79685dcf-f586-4d64-9312-ec4926b22834

> FDA 483 for Norbrook Laboratories, Ltd. on April 18, 2019. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Norbrook Laboratories, Ltd.
- Inspection Date: 2019-04-18
- Product Type: veterinary
- Office Name: Center for Veterinary Medicine
- Summary: Norbrook Laboratories, Ltd. in Newry, United Kingdom, was inspected and received a Form 483 with five observations. The inspection revealed significant issues in quality control, including inadequate investigations into sterility failures and rejected batches, and a data integrity breach. Additionally, the firm failed to follow stability testing protocols, submit a timely Field Alert Report, and maintain adequate written procedures for production controls and visual inspector qualifications.

## Related Documents

- [483 - 2020-02-07](https://www.globalkeysolutions.net/records/483/norbrook-laboratories-ltd/13828f63-b414-4307-adf6-a557aaf5d7ca)

## Related Officers

- [Ileana Barreto-Petit](https://www.globalkeysolutions.net/people/ileana-barreto-petit/e5c865ac-14a2-47d4-954b-464a865e8684)

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