# FDA 483 - CTX Lifesciences Private Limited - September 02, 2022

Source: https://www.globalkeysolutions.net/records/483/ctx-lifesciences-private-limited/90a131a0-92b6-4343-8a31-2a5bfabaf26c

> FDA 483 for CTX Lifesciences Private Limited on September 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CTX Lifesciences Private Limited
- Inspection Date: 2022-09-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: CTX Lifesciences Private Limited, an Active Pharmaceutical Ingredient (API) manufacturer in Surat, India, received a Form 483 for significant deficiencies in its quality system. The inspection revealed failures in process and cleaning validations, inadequate review of discrepancies, poor computer system controls, and issues with equipment design, cleaning, and batch record keeping. These findings indicate a lack of adherence to Current Good Manufacturing Practices (CGMP) for API production.

## Related Officers

- [Yvins Dezan](https://www.globalkeysolutions.net/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)
- [Investigator](https://www.globalkeysolutions.net/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

Company: https://www.globalkeysolutions.net/companies/ctx-lifesciences-private-limited/26d2684f-09dd-419d-87cb-53196b1fd868

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