# FDA 483 - Amneal Pharmaceuticals Private Ltd. - April 24, 2018

Source: https://www.globalkeysolutions.net/records/483/amneal-pharmaceuticals-private-ltd/ca761aa3-3f67-47d0-8e0a-ec569a845796

> FDA 483 for Amneal Pharmaceuticals Private Ltd. on April 24, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amneal Pharmaceuticals Private Ltd.
- Inspection Date: 2018-04-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Amneal Pharmaceuticals Pvt Ltd. in Matoda, India, was inspected from April 16-24, 2018, and received a Form 483 for significant deficiencies in its quality control unit. The firm's quality control unit failed to adequately review raw data and deviations from contract laboratories for various tests, including method validations and API testing, before approving data and releasing products. This indicates a critical breakdown in oversight of outsourced testing and product release procedures.

## Related Documents

- [483 - 2018-04-24](https://www.globalkeysolutions.net/records/483/amneal-pharmaceuticals-private-ltd/244d0cc8-eaef-4da5-956f-0bd2773d8823)
- [483 - 2022-12-23](https://www.globalkeysolutions.net/records/483/amneal-pharmaceuticals-private-ltd/4e198411-7bc6-4beb-bf08-921ec3ec35e8)
- [483 - 2022-12-23](https://www.globalkeysolutions.net/records/483/amneal-pharmaceuticals-private-ltd/b6047e86-e443-40b8-8261-c624ee2c233e)
- [483 - 2024-06-19](https://www.globalkeysolutions.net/records/483/amneal-pharmaceuticals-private-ltd/f120f87b-ed0a-4330-8dcd-f96c87af7321)

## Related Officers

- [Consumer Safety Officer/ORA/OMPTO/TOS](https://www.globalkeysolutions.net/people/niketa-patel/73efe456-da61-4345-8dec-7147b12b88d1)
- [Microbiologist](https://www.globalkeysolutions.net/people/maria-buen-bigoarnia/e4a0e642-c954-4742-b5e9-b3fb75848432)

Company: https://www.globalkeysolutions.net/companies/amneal-pharmaceuticals-private-ltd/95002f12-1dab-4e55-82a6-bed955c79358

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