# FDA 483 - Cohance Lifesciences Limited - August 20, 2019

Source: https://www.keypedia.com/records/483/cohance-lifesciences-limited/8c879e76-371d-4358-9d13-0c7e3eb72d67

> FDA 483 for Cohance Lifesciences Limited on August 20, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cohance Lifesciences Limited
- Inspection Date: 2019-08-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of RA Chem Pharma Limited, a drug manufacturer in Hyderabad, Telangana, revealed significant deficiencies in their operations. The firm was cited for inadequate laboratory controls concerning sampling plans, issues with equipment design, cleaning, and qualification, and a lack of proper quality control unit oversight. These observations indicate a need for improved adherence to manufacturing and quality standards.

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## Related Officers

- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

Company: https://www.keypedia.com/companies/cohance-lifesciences-limited/837bc249-27a4-44f5-a518-f2deac8252f2

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