# FDA 483 - Aurobindo Pharma Limited - September 05, 2025

Source: https://www.keypedia.com/records/483/aurobindo-pharma-limited/53eddf59-189f-410e-94a4-1b28f676d6d6

> FDA 483 for Aurobindo Pharma Limited on September 05, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aurobindo Pharma Limited
- Inspection Date: 2025-09-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Aurobindo Pharma Ltd. in Bachupally, Hyderabad, revealed critical deficiencies in sterile drug product manufacturing, including inadequate aseptic processing and environmental monitoring. The firm also failed to properly investigate product complaints and batch discrepancies, and exhibited issues with process validation, equipment cleaning, and facility maintenance. These observations indicate significant non-compliance with cGMP regulations across multiple operational areas.

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- [483 - 2025-09-05](https://www.keypedia.com/records/483/aurobindo-pharma-limited/31ac5498-c32b-4f35-b9ad-a996d6e6c456)

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Claudia M. Perez-Kasmarski](https://www.keypedia.com/people/claudia-m-perez-kasmarski/ee989ba2-eb7a-47ae-8be5-7a28f748343b)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.keypedia.com/companies/aurobindo-pharma-limited/9bedb5d4-0483-4173-bc76-1c5737a28fc1

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1