# FDA 483 - CTX Lifesciences Private Ltd. - February 16, 2019

Source: https://www.globalkeysolutions.net/records/483/ctx-lifesciences-private-ltd/8e0b8a3c-e1f9-4095-96a5-fc6d8d117367

> FDA 483 for CTX Lifesciences Private Ltd. on February 16, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CTX Lifesciences Private Ltd.
- Inspection Date: 2019-02-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: CTX Lifesciences Private Ltd. in Surat, India, an API manufacturer, received a Form 483 for significant deficiencies in its quality unit's oversight of CGMP compliance. The inspection revealed failures in managing out-of-specification results, inadequate employee training, and a lack of control over transportation conditions for Active Pharmaceutical Ingredients. These issues indicate a systemic breakdown in quality assurance and control.

## Related Documents

- [WARNING_LETTER - 2019-02-16](https://www.globalkeysolutions.net/records/warning_letter/ctx-lifesciences-private-ltd/5627d577-3e2b-4ee2-853e-e5cda1af7afd)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)
- [Lata C. Mathew](https://www.globalkeysolutions.net/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)

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

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