Veranova, a global leader in the development and manufacture of specialty and complex active pharmaceutical ingredients (APIs) for the pharmaceutical and biotech sectors, has announced that its Devens, Massachusetts site has successfully completed a routine current Good Manufacturing Practice (cGMP) surveillance inspection by the Food and Drug Administration (FDA) with a “No Action Indicated” (NAI) classification and no Form 483 observations.   

The inspection, carried out by the FDA’s New England District and concluded on July 31, 2025, reinforces Veranova’s strong compliance track record at its Devens site.

An FDA Form 483 is issued when potential violations of the Food, Drug, and Cosmetic Act are observed.

“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,” said 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,” he added.

The Devens site produces multiple commercial products and provides solutions from early development through scale-up and clinical manufacturing. It is actively expanding its High Potency Active Pharmaceutical Ingredient (HPAPI) and Antibody Drug Conjugate (ADC) capacity. Recently, the site initiated a new investment in state-of-the-art Bioconjugation development and additional cGMP manufacturing capabilities.  

Headquartered in Devens, Veranova operates in North America and Europe, focusing on complex chemistry for small molecules, antibody-drug conjugates, oligonucleotides, and peptides.