# FDA 483 - Aurobindo Pharma Limited - February 21, 2020

Source: https://www.globalkeysolutions.net/records/483/aurobindo-pharma-limited/892c968e-c743-4108-bf0a-b6616316dc36

> FDA 483 for Aurobindo Pharma Limited on February 21, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aurobindo Pharma Limited
- Inspection Date: 2020-02-21
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Aurobindo Pharma Ltd in Bachupally, Telangana, revealed significant deficiencies in manufacturing practices for drug products. Observations included inadequate facilities for contamination prevention, failures in microbiological contamination control for sterile products, and insufficient employee training. The firm also demonstrated poor handling of discrepancies, out-of-specification results, and customer complaints, alongside unvalidated test methods.

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## 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