# FDA 483 - Cohance Lifesciences Limited - August 04, 2025

Source: https://www.keypedia.com/records/483/cohance-lifesciences-limited/d91419ca-2668-4ef1-bd2a-4e86ee72d065

> FDA 483 for Cohance Lifesciences Limited on August 04, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cohance Lifesciences Limited
- Inspection Date: 2025-08-04
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: Cohance Lifesciences Limited, a finished drug product manufacturer located in Secunderabad, Telangana, India, was inspected by the FDA from August 4 to August 12, 2025. The inspection revealed several critical issues primarily related to the company's quality system. Key observations included the failure to thoroughly review discrepancies and the lack of documentation regarding the disposition of rejected batches. Specifically, a batch of tablets intended for the U.S. market was rejected due to quality concerns but had not been disposed of 23 months after the decision was made.

Additionally, the company failed to conduct adequate follow-up investigations for out-of-specification (OOS) results and did not implement preventive actions to address identified process gaps. There was also a lack of documentation for extractable and leachable studies for packaging materials used for products distributed in the U.S. market.

The FDA's observations highlight significant non-compliance with regulatory expectations for quality assurance and documentation. Cohance Lifesciences is required to address these issues by implementing corrective actions, ensuring thorough investigations of discrepancies, and maintaining comprehensive records of all quality-related activities. The firm must also establish procedures for conducting and documenting extractable and leachable studies to ensure product safety and compliance with U.S. regulatory standards.

## Related Documents

- [483 - 2019-08-20](https://www.keypedia.com/records/483/cohance-lifesciences-limited/8c879e76-371d-4358-9d13-0c7e3eb72d67)
- [483 - 2025-08-12](https://www.keypedia.com/records/483/cohance-lifesciences-limited/5edde9ef-4e43-4ac5-9ca9-f2e8b88dd055)
- [483 - 2025-08-12](https://www.keypedia.com/records/483/cohance-lifesciences-limited/f178b409-2e3a-4d94-ae24-12fbc7a2cd6f)

## Related Officers

- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c