Dirty Conditions, Quality-Control Problems Found By FDA Inspectors At Plant Making J&J Shots
None of the potentially contaminated Johnson & Johnson shots produced at the Baltimore Emergency BioSolutions were ever distributed, but 15 million doses had to be discarded. The latest report says more may be compromised.
CBS News:
FDA Inspectors Find "Brown Residue" And Other Violations In Plant Making Johnson & Johnson Vaccine
The Baltimore factory contracted to make Johnson & Johnson's COVID-19 vaccine was dirty, didn't follow proper manufacturing procedures and had poorly trained staff, resulting in contamination of material that was going to be put in the shots, U.S. regulators said Wednesday. The Food and Drug Administration released a statement and a 13-page report detailing findings from its recent inspection of the now-idle Emergent BioSciences factory. Agency inspectors said a batch of bulk drug substance for J&J's single-shot vaccine was contaminated with material used to make COVID-19 vaccines for another Emergent client, AstraZeneca. That batch, reportedly enough to make about 15 million J&J vaccine doses, had to be thrown out. (4/21)
NPR:
FDA Inspection Finds Numerous Problems At Facility Intended To Make J&J Vaccine
Peeling paint. Cracked buckets. Employees dragging unsealed bags of medical waste. Procedures ignored. Inadequately trained staff. All of these were problems noted by U.S. Food and Drug Administration inspectors at the Emergent BioSolutions factory in Baltimore – a facility that is intended to produce materials for the Johnson & Johnson COVID-19 vaccine. That plan is on hold, following a problem last month with a batch of a vaccine ingredient there, and now a range of documented issues at the facility. (Wamsley, 4/21)
The New York Times:
Federal Inspectors Fear More Vaccines Were Exposed To Contamination
“There is no assurance that other batches have not been subject to cross-contamination,” the F.D.A.’s 12-page report states. The report amounted to a harsh rebuke of Emergent, which had long played down setbacks at the factory, and added to problems for Johnson & Johnson, whose vaccine had been seen as a game changer because it requires only one shot, can be produced in mass volume and is easily stored. (LaFraniere, Stolberg and Hamby, 4/21)
Politico:
FDA Inspection Report Casts Doubt On J&J Vaccine Contractor's Ability To Restart Production
Emergent said that it is working with FDA and J&J to resolve the issues quickly. "While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them," the company said in a statement. It added that "the issuance of findings by the FDA is normal following a facility inspection and provides direction on the necessary steps to improve operations." But it is rare for the agency to move so quickly —releasing a report on an inspection concluded just a day earlier — and to accompany its findings with a statement by top FDA officials. (Owermohle and Banco, 4/21)
