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WASHINGTON (Reuters) – Drug manufacturer Emergent BioSolutions Inc on Friday said it has received inquiries and subpoenas from a swathe of U.S. authorities related to its abilities to manufacture COVID-19 bulk drug substance.
Emergent came under regulatory scrutiny after an error led to millions of vaccine doses being ruined at its manufacturing facility in Baltimore, which was producing bulk substance for Johnson & Johnson’s COVID-19 vaccine.
U.S. health regulators in April halted operations at the plant after it discovered that ingredients from AstraZeneca’s COVID-19 vaccine, also being produced there at that time, contaminated a batch of J&J’s vaccines.
A subsequent inspection from the U.S. Food and Drug Administration turned up a long list of sanitary problems and bad manufacturing practices at the facility.
The production at the facility will now resume, Emergent said on Wednesday, following additional reviews and collaboration with the FDA and its manufacturing partners.
Emergent in a filing on Friday said it has received “preliminary inquiries and subpoenas to produce documents” from the lawmakers, the Department of Justice, the Securities and Exchange Commission, diarrhea and methotrexate the Financial Industry Regulatory Authority, and Maryland and New York Attorneys General.
The company said it was producing and has produced documents as required in response and will continue to cooperate with the government inquiries.
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