Veranova’s Devens Site Successfully Passes FDA Inspection With Zero Observations
Veranova recently announced that a routine current Good Manufacturing Practice (cGMP) surveillance inspection of Veranova’s Devens, Massachusetts site, completed by the Food and Drug Administration (FDA) New England District on July 31, 2025, concluded without any Form 483s and with a “No Action Indicated” (NAI) classification. This result demonstrates Veranova’s commitment to driving the highest standards of quality and compliance, and to delivering consistent and reliable product supply for customers and patients.
This FDA inspection outcome continues Veranova’s strong compliance track record at its Devens, MA, 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 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,” 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.”
Veranova is a global leader in process development and manufacturing of APIs, with a focus on specialty and complex chemistry for small molecules, antibody-drug conjugates, oligonucleotides and peptides. Veranova is headquartered in Devens, Massachusetts and has operations in North America and Europe.
Total Page Views: 285
