FDA 483 - Cohance Lifesciences Limited - August 12, 2025

**FDA 483 Summary for Executives**

**Company:** Cohance Lifesciences Limited **Inspection Dates:** August 4, 2025 - August 12, 2025 **Location:** Secunderabad, Telangana, India **FEI Number:** 3008768274 **Type of Establishment Inspected:** Finished Drug Product Manufacturer

**Main Violations/Issues:**

1. **Quality System Failures:** - Missing documentation and reconciliation for a rejected batch from August 2023, with a significant portion unaccounted for. - Inadequate investigation and preventive actions for a batch failing HPLC assay tests due to operator error. - Insufficient assessment for out-of-specification results, lacking documentation for extractable and leachable studies for packaging.

2. **Complaint Handling Deficiencies:** - Incomplete investigations and follow-ups on drug complaints, including disintegrating tablets and contamination with glove pieces. - Lack of established specifications for physical characteristics of tablets and failure to file necessary Field Alert Reports.

3. **Quality Control Unit Oversight:** - Absence of written procedures and adherence to responsibilities, particularly in logging and following up on field alert reports.

**Regulatory Framework:** The inspection was conducted under the FDA"s regulatory guidelines for drug manufacturing, focusing on compliance with Good Manufacturing Practices (GMP).

**Required Actions:** - Implement comprehensive documentation and reconciliation processes for all rejected batches. - Establish and enforce preventive measures for identified process gaps and operator errors. - Conduct thorough investigations for all complaints and ensure compliance with Field Alert Report procedures. - Develop and adhere to detailed quality control procedures, ensuring all responsibilities are documented and followed.

Cohance Lifesciences Limited must address these observations promptly to align with FDA standards and ensure the integrity of products distributed to the U.S. market.