THE BASICS
This is resulting from an inspection of the facility at One Moderna Way, Norwood, MA, FEI #3014937058, which began on September 11, 2023. FDA personnel spent nine (9) days on-site.
The 483 document is available for purchase/download here.
The 483 contains five observations, ranging from failure to properly clean manufacturing equipment, to lack of segregation of expired materials, to alarms and air handling systems.
There were four FDA Investigators involved:
- Unnee Ranjan, Lead Investigator
- Thai Truong, Investigator
- Swati Verma, Product Specialist
- Ben Firschein, Regulatory Counsel
Some of Moderna’s response is highlighted in this Reuters article.
THE BUZZ
Reuters notes that: this site is “used to manufacture the company’s COVID shot Spikevax and an experimental mRNA cancer vaccine being developed with Merck & Co“.
Moderna notes that: “Upon receipt of the FDA’s findings, Moderna immediately and comprehensively updated the specific procedures identified and is confident that the actions taken will be satisfactory to regulators.”
