Breaking News

FDA Finds QC Failures at Moderna’s Norwood Mfg. Facility

Form 483 report obtained by Reuters notes five separate observations including equipment issues and expired items.

Author Image

By: Kristin Brooks

Managing Editor, Contract Pharma

Following an inspection conducted in September 2023, the U.S. FDA found quality control issues at Moderna’s primary manufacturing facility in Norwood, MA, where the company manufactures its COVID-19 vaccine, Spikevax, and an experimental mRNA cancer vaccine being developed with Merck, according to an exclusive report obtained by Reuters via a Freedom of Information Act request.    According to Reuters, the Form 483 noted five separate observations, including that Moderna had released eight bat...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters