# FDA 483 - Norbrook Laboratories Limited - October 15, 2021

Source: https://www.keypedia.com/records/483/norbrook-laboratories-limited/d60018ac-987e-4070-a0f8-42e4c82bd6e5

> FDA 483 for Norbrook Laboratories Limited on October 15, 2021. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Norbrook Laboratories Limited
- Inspection Date: 2021-10-15
- Product Type: veterinary
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Documents

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- [483 - 2024-03-29](https://www.keypedia.com/records/483/norbrook-laboratories-limited/2f5d63bd-1519-4797-86ab-5fa154d50fbe)
- [483 - 2025-04-04](https://www.keypedia.com/records/483/norbrook-laboratories-limited/0cc0b28f-69ba-4889-b2bd-e0330e18efb6)

## Related Officers

- [Investigator](https://www.keypedia.com/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)
- [Jennifer L. Huntington](https://www.keypedia.com/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.keypedia.com/companies/norbrook-laboratories-limited/c9294f28-e127-43a0-b824-82a6f41fabfd

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1