Amol Pharmaceuticals Private Ltd.March 24, 2025

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

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Record Details

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.

Company: Amol Pharmaceuticals Private Ltd.
Inspection Date: March 24, 2025
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Lisa L. Flores (Consumer Safety Officer/ Federal Investigator)

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ID · 916d3e2b-a5e0-4757-af4f-27be258b54c0