# FDA 483 - Cephas Life Sciences Private Limited - May 18, 2023

Source: https://www.globalkeysolutions.net/records/483/cephas-life-sciences-private-limited/8c272a57-7bfc-4e27-ae08-99b424cf4021

> FDA 483 for Cephas Life Sciences Private Limited on May 18, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cephas Life Sciences Private Limited
- Inspection Date: 2023-05-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Cephas Life Sciences Private Limited, a chemical analytical laboratory in Taramani, Chennai, received a Form 483 with three observations. The inspection revealed deficiencies in laboratory controls, including scientifically unsound out-of-specification procedures and unsupported extraction methods. Additionally, the firm failed to justify deviations from written sampling plans and lacked a quality agreement for contract manufactured drug products.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.globalkeysolutions.net/companies/cephas-life-sciences-private-limited/e3f3dd0f-ef6a-478d-ab12-3d08626f0ebb

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