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Emergent BioSolutions is promising the FDA a series of fixes in response to an inspection that led to production stopping at the company's Bayview facility in Baltimore, which had been making Johnson & Johnson's COVID-19 vaccine, reported Bloomberg.
An FDA inspection identified nine concerns including unsanitary conditions and ineffective practices for preventing cross-contamination at Emergent’s facility.
The FDA has requested Emergent’s Bayview plant be closed and vaccine production halted while the agency investigates potential good manufacturing practice (GMP) violations.