(Reuters) – Drug maker Emergent BioSolutions Inc. on Friday said it had received inquiries and lawsuits from a number of U.S. authorities related to its ability to manufacture COVID-19 bulk drugs.
Emergent came under supervision after an error led to the destruction of millions of vaccine doses at the Baltimore manufacturing facility, which produced bulk material for Johnson & Johnson's COVID-19 vaccine.
US health regulators in April halted operations at the facility after discovering that ingredients from AstraZeneca's COVID-19 vaccine, which was also produced there at the time, contaminated a batch of J & J's vaccines.
Production at the facility will now resume, Emergent said Wednesday, following further reviews and collaboration with the U.S. Food and Drug Administration and its manufacturing partners.
Emergent in an application on Friday said it had received "preliminary requests and summonses to produce documents" from lawmakers, the Department of Justice, Securities and Exchange Commission, the Financial Industry Regulatory Authority and attorneys in Maryland and New York.
The company said it produced and produced documents as needed and will continue to cooperate with government inquiries. Catalog