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Flamma USA Successfully Passes FDA Inspection

PAI took place over four days for an API that the Malvern, PA site will manufacture for a global pharma company.

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By: Kristin Brooks

Managing Editor, Contract Pharma

The Flamma Group, a global CDMO of New Chemical Entities (NCEs) and late stage intermediates for innovator companies, has successfully passed its first U.S. FDA inspection of its Flamma USA site in Malvern, PA, The pre-approval inspection (PAI) took place over the course of four days for an API that the Flamma USA site will manufacture for a global pharmaceutical company. The inspection covered the entire facility including the manufacturing equipment and quality system, and the site was fo...

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