# FDA 483 - BROOKS STERISCIENCE LIMITED - February 01, 2023

Source: https://www.keypedia.com/records/483/brooks-steriscience-limited/45ef072d-7271-45bc-8936-4d43a40414e5

> FDA 483 for BROOKS STERISCIENCE LIMITED on February 01, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BROOKS STERISCIENCE LIMITED
- Inspection Date: 2023-02-01
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of BROOKS STERISCIENCE LIMITED, a sterile drug products manufacturer in Vadodara, Gujarat, India, revealed significant deficiencies. The firm failed to establish procedures to prevent microbiological contamination, specifically regarding aseptic process simulations that did not accurately represent actual manufacturing conditions. Additionally, the accuracy and sensitivity of cleaning verification test methods were not established, lacking proper documentation for swab identification, recovery factors, and limits of quantification.

## Related Officers

- [Jose M. Cayuela](https://www.keypedia.com/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.keypedia.com/companies/brooks-steriscience-limited/9d0997f7-e7c0-4eb4-a61e-8c0911ba54d6

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321