# FDA 483 - Amol Pharmaceuticals Private Ltd. - March 24, 2025

Source: https://www.globalkeysolutions.net/records/483/amol-pharmaceuticals-private-ltd/916d3e2b-a5e0-4757-af4f-27be258b54c0

> FDA 483 for Amol Pharmaceuticals Private Ltd. on March 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amol Pharmaceuticals Private Ltd.
- Inspection Date: 2025-03-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Amol Pharmaceuticals Private Ltd, a human contract drug manufacturer in Rajasthan, India, was inspected. The inspection revealed one observation regarding the firm's failure to adequately test raw materials for potential contamination. Specifically, the firm did not perform testing for (b)(4) contamination in a raw material used for tablet production against established specifications.

## Related Documents

- [483 - 2018-02-16](https://www.globalkeysolutions.net/records/483/amol-pharmaceuticals-private-ltd/0b5934a4-2c98-44ea-ba0b-82991d8b73b0)
- [483 - 2019-09-13](https://www.globalkeysolutions.net/records/483/amol-pharmaceuticals-private-ltd/8f659989-65ba-4ca7-8948-2d401528d448)

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.globalkeysolutions.net/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

Company: https://www.globalkeysolutions.net/companies/amol-pharmaceuticals-private-ltd/25109535-73e8-434b-98f1-01695cc33434

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