# FDA 483 - Norbrook Laboratories Limited - April 04, 2025

Source: https://www.keypedia.com/records/483/norbrook-laboratories-limited/0cc0b28f-69ba-4889-b2bd-e0330e18efb6

> FDA 483 for Norbrook Laboratories Limited on April 04, 2025. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Norbrook Laboratories Limited
- Inspection Date: 2025-04-04
- Product Type: veterinary
- Office Name: Office of Inspections and Investigations
- Summary: Norbrook Laboratories Limited, an animal drug product manufacturer, received a Form 483 with seven observations indicating significant deficiencies across multiple quality systems. The inspection revealed critical issues including inadequate sterile manufacturing procedures, environmental monitoring failures, deficient OOS investigations, non-stability-indicating analytical methods, poor equipment cleaning, lack of data integrity for QC testing, and inadequate complaint handling. These findings led to Field Alert Reports and a halt in manufacturing and distribution of sterile drug products to the U.S. market.

## 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 - 2024-03-29](https://www.keypedia.com/records/483/norbrook-laboratories-limited/2f5d63bd-1519-4797-86ab-5fa154d50fbe)

## Related Officers

- [Pratik S. Upadhyay](https://www.keypedia.com/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8