# FDA 483 - Atul Bioscience Ltd. - September 10, 2022

Source: https://www.globalkeysolutions.net/records/483/atul-bioscience-ltd/ac0a023b-af5b-467a-bd32-5865e9ae608d

> FDA 483 for Atul Bioscience Ltd. on September 10, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Atul Bioscience Ltd.
- Inspection Date: 2022-09-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Atul Bioscience Ltd. in Valsad, India, was cited for significant deficiencies in its manufacturing processes during an FDA inspection. Observations included inadequate cleaning processes and validation, insufficient investigation documentation for OOS and complaints, and a lack of proper equipment qualification and maintenance records. These issues indicate a systemic failure to ensure product quality and prevent cross-contamination.

## Related Officers

- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.globalkeysolutions.net/companies/atul-bioscience-ltd/4e09e135-2b9d-4cda-b82e-87bff3309681

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