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

Source: https://www.keypedia.com/records/483/aurobindo-pharma-limited/f9105441-a42a-4c5a-b2bb-c661c52107ce

> 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: Office of Biological Products Operations - Division I
- Summary: Aurobindo Pharma Limited, Unit-VI in Polepaur, India, a sterile and non-sterile drug manufacturer, was inspected by the FDA from September 22-29, 2023. The inspection revealed a failure to establish adequate control procedures for manufacturing processes, specifically concerning the monitoring of packaging hold times. The firm's Quality Unit did not implement comprehensive corrective and preventive actions to address 35 batches that exceeded established hold times, a deficiency noted as a repeat observation from a previous inspection.

## 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)

## 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/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1