# FDA 483 - Aurobindo Pharma Limited - September 29, 2023

Source: https://www.keypedia.com/records/483/aurobindo-pharma-limited/0a8f426c-7b66-416c-8ea8-43743e6eea6f

> FDA 483 for Aurobindo Pharma Limited on September 29, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aurobindo Pharma Limited
- Inspection Date: 2023-09-29
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: Aurobindo Pharma Limited, Unit-VI in Penapur, India, was inspected from September 22-29, 2023, and received one observation. The firm failed to establish adequate control procedures to monitor manufacturing processes, specifically regarding the management of packaging hold times. This is a repeat observation, indicating a persistent issue with ensuring product quality and process control.

## Related Documents

- [483 - 2017-09-01](https://www.keypedia.com/records/483/aurobindo-pharma-limited/fa87938a-b662-486e-8dc7-6453768cfc90)
- [WARNING_LETTER - 2019-02-09](https://www.keypedia.com/records/warning_letter/aurobindo-pharma-limited/d3443fe6-06c1-4cca-9cf2-4e6642d8b4ef)
- [483 - 2023-09-29](https://www.keypedia.com/records/483/aurobindo-pharma-limited/f9105441-a42a-4c5a-b2bb-c661c52107ce)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [Jennifer L. Huntington](https://www.keypedia.com/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.keypedia.com/companies/aurobindo-pharma-limited/526fd1b4-90b1-4e91-b9f5-a3eab997ed60

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c