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

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.