# FDA 483 - Norbrook Laboratories Limited - March 29, 2024

Source: https://www.keypedia.com/records/483/norbrook-laboratories-limited/2f5d63bd-1519-4797-86ab-5fa154d50fbe

> FDA 483 for Norbrook Laboratories Limited on March 29, 2024. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Norbrook Laboratories Limited
- Inspection Date: 2024-03-29
- Product Type: veterinary
- Office Name: Center for Veterinary Medicine
- Summary: Norbrook Laboratories Limited, an animal drug product manufacturer in Newry, United Kingdom, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate procedures to prevent microbiological contamination of sterile drug products, failures in out-of-specification (OOS) investigations, and incomplete batch production and control records. These issues indicate a lack of robust quality control and aseptic processing practices.

## Related Documents

- [483 - 2019-07-26](https://www.keypedia.com/records/483/norbrook-laboratories-limited/e97e28e6-04d8-48f6-a2c7-a2d729eb4c8e)
- [483 - 2021-10-15](https://www.keypedia.com/records/483/norbrook-laboratories-limited/d60018ac-987e-4070-a0f8-42e4c82bd6e5)
- [483 - 2025-04-04](https://www.keypedia.com/records/483/norbrook-laboratories-limited/0cc0b28f-69ba-4889-b2bd-e0330e18efb6)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

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

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