# FDA 483 - NATCO Pharma Limited Chemical Division Chennai - November 21, 2025

Source: https://www.keypedia.com/records/483/natco-pharma-limited-chemical-division-chennai/ccd7fa17-7d9c-41c1-b8eb-fad2bb3518c9

> FDA 483 for NATCO Pharma Limited Chemical Division Chennai on November 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NATCO Pharma Limited Chemical Division Chennai
- Inspection Date: 2025-11-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: NATCO Pharma Limited Chemical Division, an API manufacturer in Chennai, India, was cited for significant deficiencies during an FDA inspection. Observations included inadequate OOS investigations and CAPA implementation, unvalidated manufacturing processes, and poor laboratory and equipment controls. The firm also demonstrated issues with quality unit procedures, facility maintenance, and computer system controls, indicating a broad lack of adherence to cGMP requirements.

## Related Documents

- [483 - 2025-06-19](https://www.keypedia.com/records/483/natco-pharma-limited-chemical-division-chennai/2ce2ef17-813a-446e-9898-a324eb76b89a)

## Related Officers

- [investigator](https://www.keypedia.com/people/timothy-h-vo/08da7ca5-7f58-42bf-8046-e3a1bf879b48)
- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.keypedia.com/companies/natco-pharma-limited-chemical-division-chennai/c2978c98-d900-4777-9b55-7c62f09edfe0

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8