# FDA 483 - Aurobindo Pharma Limited - February 17, 2020

Source: https://www.globalkeysolutions.net/records/483/aurobindo-pharma-limited/733cada2-a1ca-47e0-b637-93e8c8b28dd8

> FDA 483 for Aurobindo Pharma Limited on February 17, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Aurobindo Pharma Limited
- Inspection Date: 2020-02-17
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Aurobindo Pharma Ltd in Bachupally, Telangana, revealed significant deficiencies in their manufacturing operations. Observations included inadequate facilities and procedures to prevent contamination of sterile drug products, insufficient employee training, and a failure to thoroughly investigate discrepancies and out-of-specification results. The firm also demonstrated inadequate procedures for handling product complaints and validating test methods.

## Related Documents

- [483 - 2020-02-21](https://www.globalkeysolutions.net/records/483/aurobindo-pharma-limited/892c968e-c743-4108-bf0a-b6616316dc36)
- [483 - 2025-09-05](https://www.globalkeysolutions.net/records/483/aurobindo-pharma-limited/31ac5498-c32b-4f35-b9ad-a996d6e6c456)
- [483 - 2025-09-05](https://www.globalkeysolutions.net/records/483/aurobindo-pharma-limited/53eddf59-189f-410e-94a4-1b28f676d6d6)

## Related Officers

- [Xiaohong Lu](https://www.globalkeysolutions.net/people/xiaohong-lu/c090ea51-c732-4d96-8063-30a8f2eb21ba)
- [Advisor](https://www.globalkeysolutions.net/people/frederick-razzaghi/7346f6ec-1d9a-4ad3-abde-0497dcd9c8b5)

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

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321