# FDA 483 - Choksi Laboratories Limited - June 01, 2016

Source: https://www.globalkeysolutions.net/records/483/choksi-laboratories-limited/b93da304-bd64-4971-b9c1-b719c54b43db

> FDA 483 for Choksi Laboratories Limited on June 01, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Choksi Laboratories Limited
- Inspection Date: 2016-06-01
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Choksi Laboratories Ltd. in Indore, India, a control testing laboratory, revealed significant deficiencies in laboratory records and data integrity practices. The firm failed to maintain complete data, ensure data reporting, review electronic raw data and audit trails, and properly document changes. Additionally, the quality control unit lacked adequate written procedures, approval responsibilities, and scientifically sound laboratory controls for specifications and chemical shelf-life.

## Related Documents

- [483 - 2018-04-25](https://www.globalkeysolutions.net/records/483/choksi-laboratories-limited/8d15e946-1b95-4570-9dd7-0b39fb7260f3)
- [483 - 2019-09-06](https://www.globalkeysolutions.net/records/483/choksi-laboratories-limited/a7901596-1627-4dec-af3c-10538d725cc2)

## Related Officers

- [Cheryl A. Clausen](https://www.globalkeysolutions.net/people/cheryl-a-clausen/2306b2bc-8f01-4f77-ba2d-1a3186d6f6fc)

Company: https://www.globalkeysolutions.net/companies/choksi-laboratories-limited/9dd2f413-47cd-4d9e-916a-96a24127522c

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