# FDA 483 - CTX Lifesciences Private Ltd. - September 02, 2022

Source: https://www.keypedia.com/records/483/ctx-lifesciences-private-ltd/5f62b2ef-bab4-48fc-9bd6-31e5bcecbd65

> FDA 483 for CTX Lifesciences Private Ltd. 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 Ltd.
- 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 Documents

- [483 - 2019-02-16](https://www.keypedia.com/records/483/ctx-lifesciences-private-ltd/8e0b8a3c-e1f9-4095-96a5-fc6d8d117367)
- [WARNING_LETTER - 2019-02-16](https://www.keypedia.com/records/warning_letter/ctx-lifesciences-private-ltd/5627d577-3e2b-4ee2-853e-e5cda1af7afd)

## Related Officers

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

Company: https://www.keypedia.com/companies/ctx-lifesciences-private-ltd/cbf6df36-d316-40a9-891a-10cbbb4e757f

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