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Veranova’s Devens Site Passes FDA Inspection 

The site is also expanding its High Potency Active Pharmaceutical Ingredient and Antibody Drug Conjugate capacity.

By: Rachel Klemovitch

Assistant Editor

Veranova, a leader in the development and manufacture of specialty and complex active pharmaceutical ingredients (API) for the pharmaceutical and biotech sectors, announced that a routine current Good Manufacturing Practice (cGMP) surveillance inspection of Veranova’s Devens, Massachusetts site, completed by the FDA New England District on July 31, 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 and recently initiated a new investment in 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.”

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