Veranova announces that a routine current good manufacturing practice (cGMP) surveillance inspection of Veranova’s Devens, Massachusetts site — completed by the US Food and Drug Administration (FDA) New England District on 31 July 2025 — concluded without any Form 483s and with a “No Action Indicated” (NAI) classification.
This FDA inspection outcome continues Veranova’s strong compliance track record at its Devens, Massachusetts site, which produces multiple commercial products and provides solutions from early development through scale-up and clinical manufacturing.
The site is actively expanding its high-potency active pharmaceutical ingredient (HPAPI) and antibody drug conjugate (ADC) capacity.
The company recently invested in state-of-the-art bioconjugation development and additional cGMP manufacturing capabilities.
“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,” says Lucas Sauer-Jones, Vice President and General Manager of Veranova, New England.
“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.”
