WASHINGTON, July 30 (Reuters) - Drug manufacturer Emergent
BioSolutions Inc said on Friday it has received
inquiries and subpoenas from a swathe of U.S. authorities
related to its abilities to manufacture COVID-19 bulk drug
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 drug substance
for Johnson & Johnson's COVID-19 vaccine.
The U.S. Food and Drug Administration (FDA) 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.
Emergent in a filing https://investors.emergentbiosolutions.com/node/20661/html
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,
the Financial Industry Regulatory Authority, and Maryland and
New York Attorneys General.
The Department of Justice declined to comment on the matter.
Emergent said it was producing and has produced documents as
required in response and will continue to cooperate with the
An FDA inspection in April turned up a long list of sanitary
problems and bad manufacturing practices at the facility,
including failure to train personnel to avoid cross
contamination of COVID-19 vaccines from J&J and AstraZeneca.
Emergent said on Wednesday production at the Baltimore
facility will now resume, following remedial actions, additional
reviews and collaboration with the FDA and its manufacturing
An FDA spokesperson said on Thursday the facility has not
yet received any authorization for a COVID-19 vaccine, but may
produce vaccine substance in advance of future inspections by
the health regulator.
(Reporting by Chris Prentice in Washington and Manojna
Maddipatla in Bengaluru; Editing by Bernard Orr and Shounak