FDA offers scathing review of Emergent plant's sanitary conditions, employee training after halting production
The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.
The first of nine observations in the Form 483, following a nine-day inspection, deals with the fact that Emergent failed to thoroughly investigate the vaccine drug substance mix-up that caused the firm to throw away 15 million doses of the J&J vaccine.
“There is no assurance that other batches have not been subject to cross-contamination,” the FDA writes.
The second observation deals with the fact that the facility is filthy.
In addition to chipping paint on the walls and floors that mean the surfaces cannot be adequately cleaned, FDA notes that waste generated during the manufacture of vaccine drug substance is not decontaminated before being transported through the warehouse and adjacent areas.
According to security camera footage, employees in one of the manufacturing areas in January and February were “observed throwing unsealed bags of special medical waste into the service elevator accessing the warehouse corridor,” the 483 notes. The third observation also raised concerns about the size of the facility, which was overcrowded with materials readied to be manufactured.
Employees were also observed in February and as recently as mid-April dragging unsealed bags of medical waste from one manufacturing area across the floor to the warehouse, as well as removing protective garments onto the warehouse floor where raw materials were being readied for manufacture.
The fifth and sixth observations note that Emergent did not properly handle and store viral bulk drug substances to prevent cross contamination and did not have proper procedures for decontaminating waste.
Emergent’s failure to train employees is documented in the seventh observation, which notes personnel involved in the manufacturing operations entered into the manufacturing area while processing of some bulk drug substance was taking place, and then entered other operational rooms without properly adhering to gowning procedures.
“Personnel involved in manufacturing operations dragged non-disinfected and non-decontaminated special medical waste” from one manufacturing area across the warehouse corridor, FDA noted.
FDA said in a statement Wednesday, “At the agency’s request, Emergent BioSolutions has agreed to pause new production while it works with the FDA to resolve potential quality issues. For the vaccines already manufactured, the products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distribution.”
The agency raised similar concerns with the plant, following an inspection in April 2020.
Emergent said in a statement that it’s committed to “working with the FDA and Johnson & Johnson to quickly resolve the issues identified.”
