# FDA 483 - RA Chem Pharma Limited - Unknown Date

Source: https://www.keypedia.com/records/483/ra-chem-pharma-limited/c629bf7c-832c-4d04-9b18-babd5ba14e3b

> FDA 483 for RA Chem Pharma Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RA Chem Pharma Limited
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of RA Chem Pharma Limited, a bioequivalence testing facility in Hyderabad, India, revealed significant deficiencies in both clinical and bioanalytical study practices. Observations included failures in maintaining test article integrity, inaccurate data recording, and inadequate documentation and control over analytical processes. These issues indicate a lack of robust controls over study integrity and data accuracy.

## Related Officers

- [investigator](https://www.keypedia.com/people/sripal-r-mada/38ce7c12-1405-436b-ac3e-55149c953537)
- [Linda R. Kuchenthal](https://www.keypedia.com/people/linda-r-kuchenthal/82483569-3091-460f-aae1-a67271bc5d9a)

Company: https://www.keypedia.com/companies/ra-chem-pharma-limited/c07ddc23-6f1f-44a8-81c3-aef826c72c1d

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321