# FDA 483 - Aurobindo Pharma Limited - May 10, 2022

Source: https://www.keypedia.com/records/483/aurobindo-pharma-limited/cdc2cd57-b94d-4778-9f26-a81d8d0d6db3

> FDA 483 for Aurobindo Pharma Limited on May 10, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aurobindo Pharma Limited
- Inspection Date: 2022-05-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Aurobindo Pharma Limited, a drug manufacturer in Polepally, India, was cited for significant deficiencies across its quality system. The inspection revealed inadequate investigations into out-of-specification results, a lack of validated production and process controls, and failures in following stability testing programs. Additionally, issues with data integrity, incomplete batch records, and inappropriate equipment design were noted, indicating a systemic breakdown in ensuring drug product quality and purity.

## Related Documents

- [483 - 2019-09-27](https://www.keypedia.com/records/483/aurobindo-pharma-limited/7bfb2b5e-0991-4dcb-861b-ef0d934ade3d)
- [483 - 2022-05-10](https://www.keypedia.com/records/483/aurobindo-pharma-limited/32976071-2001-4f14-887c-76d96e0a30e8)
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- [483 - 2026-02-10](https://www.keypedia.com/records/483/aurobindo-pharma-limited/fa93be5a-0031-4676-b411-4813d0c7f1aa)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.keypedia.com/companies/aurobindo-pharma-limited/95bcc3b3-09a1-4249-af2f-5c83de789b76

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