FDA Finds Flaws at Vaccine Factory, Accepts Moderna’s Assurances
- FDA clears some batches of Moderna shot from Catalent for use
- Catalent says it’s addressing concerns raised by officials
Moderna Covid-19 vaccine.
Photographer: David Paul Morris/BloombergThis article is for subscribers only.
US inspectors found shortcomings at a Catalent Inc. factory that produces Covid-19 shots but allowed some doses to be cleared for use after receiving assurances from vaccine maker Moderna Inc.
Some pharmaceuticals produced at the plant had visible particles that the company failed to thoroughly look into, investigators with the US Food and Drug Administration said in a report released Tuesday. Catalent received 179 complaints about particles over two years, the agency said.