# FDA 483 - NATCO Pharma Limited - June 19, 2025

Source: https://www.keypedia.com/records/483/natco-pharma-limited/f7f3273d-2be6-4f68-9f8f-a170de0e988e

> FDA 483 for NATCO Pharma Limited on June 19, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NATCO Pharma Limited
- Inspection Date: 2025-06-19
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of NATCO Pharma Limited in Rangareddy, India, a sterile and non-sterile drug manufacturer, revealed significant deficiencies across its aseptic processing operations and quality control systems. Key issues included severe data integrity problems with environmental monitoring, inadequate aseptic process validation, poor facility maintenance, and a lack of thorough investigations into discrepancies and quality events. The findings indicate a systemic breakdown in quality oversight and adherence to cGMP requirements, particularly concerning sterile drug product manufacturing.

## Related Documents

- [483 - 2017-01-24](https://www.keypedia.com/records/483/natco-pharma-limited/2a205475-5923-4695-9193-3ade2ddbebb2)
- [483 - 2019-06-05](https://www.keypedia.com/records/483/natco-pharma-limited/0bf5ef08-8bd5-4fcd-a591-64b19920b76d)
- [483 - 2023-10-18](https://www.keypedia.com/records/483/natco-pharma-limited/692230d1-0594-4320-ba99-2ef453417bd4)
- [483 - 2023-10-18](https://www.keypedia.com/records/483/natco-pharma-limited/10dc5409-7a8f-438a-84ec-a39ae77c0ab3)

## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)
- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.keypedia.com/companies/natco-pharma-limited/4c97e2d8-0023-4572-966f-d396e8fecc05

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