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

Source: https://www.globalkeysolutions.net/records/483/ctx-lifesciences-private-limited/5f62b2ef-bab4-48fc-9bd6-31e5bcecbd65

> 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: An FDA inspection of CTX Lifesciences Private Limited in Surat, Gujarat, India, revealed significant deficiencies in the manufacturing of Active Pharmaceutical Ingredients (APIs). The firm's quality unit failed to ensure CGMP compliance, with issues spanning process and cleaning validation, discrepancy investigations, and data integrity. These observations indicate a lack of adequate controls and oversight in critical manufacturing and quality assurance processes.

## 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/71a9ba29-f52d-4fc3-9b92-8af3ad7a27d5

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