- Veranova’s Devens, Massachusetts site completed a routine FDA cGMP surveillance inspection on July 31, 2025, with a “No Action Indicated” (NAI) classification and no Form 483 observations.
- The site produces multiple commercial products and is expanding its HPAPI and ADC capacity, including new bioconjugation development and cGMP manufacturing capabilities.
Veranova, a global developer and manufacturer of specialty and complex active pharmaceutical ingredients (APIs), has successfully completed a routine cGMP surveillance inspection at its Devens, Massachusetts site. The inspection, conducted by the FDA New England District on July 31, 2025, concluded with a “No Action Indicated” (NAI) classification and no Form 483 observations.
The Devens facility supports multiple commercial products and provides services spanning early development, scale-up, and clinical manufacturing. The site is currently expanding its High Potency Active Pharmaceutical Ingredient (HPAPI) and Antibody Drug Conjugate (ADC) capabilities. Recent investments include new bioconjugation development and additional cGMP manufacturing infrastructure.
Lucas Sauer-Jones, Vice President and General Manager of Veranova, New England, said: “This successful inspection outcome is one crucial piece in a more comprehensive approach to strengthening and growing our Devens operation, underpinned by a rigorous, continuous quality improvement plan. We are happy with this outcome but continue to work hard and redouble our efforts every day to ensure we maintain this same standard for our customers, and ultimately the patients, who derive the most value from our work.”
Veranova continues to position its Devens site as a hub for advanced API development and contract manufacturing, supporting the production of complex molecules, HPAPIs, and ADCs for global clients.
