FDA inspectors visited Catalent's Bloomington facility in October 2019, and found that it had problems with making sure sterile products weren't contaminated with bacterial or fungal particles.
Inspectors also wrote that the facility had problems storing pharmaceuticals at the right temperature and humidity levels.
In September, the Indiana facility received another visit from the FDA.
Inspectors again found that the employees weren't following rules to prevent microbial contamination.
For example, employees weren't making sure sterile forceps didn't touch non-sterile surfaces, and they didn't follow rules around sanitizing gloved hands in certain situations involving vials and syringes.
"These are easy to fix," says Dinesh Thakur, who raised the alarm about quality-control problems at generics drugmaker Ranbaxy, resulting in a 2013 guilty plea and a $500 million settlement. "This is like, you know, within a week, you can try and get this thing wrapped up properly."
He called it "really concerning." "If you're told in 2019 to fix it, you have a year to fix it and we have to make the same observation another time? Then that would cause me to become a little concerned."
Catalent spokesperson Chris Halling told NPR in an email that the facility was able to resolve its findings and satisfy the FDA in 2019 and 2020.
Moderna declined to comment.
Catalent is filling vials and getting them ready to send around the country, but other facilities are responsible for making the mRNA, the key substance at the heart of the vaccine, that Catalent puts in those vials.
Another well-known contract manufacturing company, Lonza, told investors in October that it is working with Moderna to make its coronavirus vaccine drug substance. Lonza is using two sites: one in Portsmouth, N.H., and another in Visp, Switzerland. The Moderna vaccine substance the new Swiss that facility makes won't be bound for the United States.
Moderna has said that it's using a relatively new facility in Norwood, Mass., to make the vaccine.
Although the facility was built in 2018, it wasn't registered with the FDA until this week and has never been inspected, records show. Typically, new facilities need to be inspected before the agency will allow their products to be released.
"While the design of the facility is based on current standards for biotechnology facilities, it has not been reviewed or pre-approved by any regulatory agency, nor has the facility been inspected by any regulatory agency such as the FDA," the company wrote in a June 2020 regulatory filing.
