# FDA 483 - Aurobindo Pharma Ltd - May 24, 2019

Source: https://www.keypedia.com/records/483/aurobindo-pharma-ltd/ed01b8a9-88db-401b-b91c-4b4446c83461

> FDA 483 for Aurobindo Pharma Ltd on May 24, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Aurobindo Pharma Ltd
- Inspection Date: 2019-05-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Aurobindo Pharma Ltd in Medchal, India, received a Form 483 with 10 observations during an inspection from May 13-24, 2019. The observations highlight significant deficiencies in quality control, data integrity, equipment cleaning, complaint handling, and computer system controls, indicating a lack of adherence to cGMP regulations. These issues raise concerns about the quality and reliability of drug products manufactured at the facility.

## Related Documents

- [483 - 2017-04-18](https://www.keypedia.com/records/483/aurobindo-pharma-ltd/96bc5d60-2e90-4ff4-a4e9-85bdabf692db)
- [483 - 2018-12-14](https://www.keypedia.com/records/483/aurobindo-pharma-ltd/f2b68946-1a20-4c83-b130-07cf6893348c)
- [483 - 2023-07-21](https://www.keypedia.com/records/483/aurobindo-pharma-ltd/33feb8af-e76c-4b11-bcf0-12ef27f2e475)

## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.keypedia.com/companies/aurobindo-pharma-ltd/169fdedf-28b5-446b-84f4-65ca9bc54a1a

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