- Flamma Group has successfully passed its first U.S. FDA pre-approval inspection at its Malvern, Pennsylvania site.
- The inspection covered API manufacturing operations and confirmed compliance with FDA GMP requirements.
Flamma Group, a contract development and manufacturing organization (CDMO) focused on new chemical entities and late-stage intermediates, announced that its Flamma USA site in Malvern, Pennsylvania has passed its first U.S. Food and Drug Administration (FDA) inspection. The four-day pre-approval inspection (PAI) was conducted for an active pharmaceutical ingredient (API) to be manufactured for a global pharmaceutical company.
The FDA inspection covered the full facility, including manufacturing equipment and the quality system. The site was found to be compliant with all FDA GMP requirements. The Malvern facility was acquired by Flamma in late 2019 and has since received more than $3 million in investments to align operations with the company’s manufacturing and quality standards.
The site focuses on early-stage small molecule drug development and the manufacture of APIs, including small-volume, orphan, and niche indication products. It includes five GMP kilo labs, a GMP high-potency API suite, a GMP pilot plant, a GMP clean room, and an R&D laboratory with 16 hoods.
“This milestone serves as a testament to our enduring commitment to the highest standards of quality and regulatory compliance.”
Gianmarco Negrisoli, President of Flamma USA
The company recently appointed Craig Dixon as Site Director. Dixon brings more than 25 years of industry experience across development, commercial, and operations within the CDMO marketplace.
