- The FDA concluded its inspection of Emergent BioSolutions Inc’s EBS troubled vaccine manufacturing plant in Baltimore after it stopped production on Monday.
- The agency released a couple of blistering observations on the cross-contamination, sanitary issues, and lack of staff training that caused ingredient mix-ups at the facility.
- The first of nine observations in Form 483 suggested that Emergent failed a thorough investigation of the vaccine drug substance mix-up that caused the firm to dump 15 million doses of the Johnson & Johnson’s JNJ vaccine.
- “There is no assurance that other batches have not been subject to cross-contamination,” the FDA writes.
- The agency observed that the facility is filthy, with chipping paint on the walls and floors. FDA notes that waste generated during the manufacture of vaccine drug substances is not decontaminated before being transported through the warehouse and adjacent areas.
- Employees in one of the manufacturing areas were “observed throwing unsealed bags of special medical waste into the service elevator accessing the warehouse corridor,” the 483 notes.
- It was also observed that employees dragged unsealed bags of medical waste from one manufacturing area across the floor to the warehouse and removed protective garments onto the warehouse floor where raw materials were being readied for manufacture.
- The company did not correctly handle and store viral bulk drug substances to prevent cross-contamination and did not have proper procedures for decontaminating waste.
- Untrained employees are documented in the seventh observation.
- The last two observations dealt with inadequate size and cleaning of utensils and equipment.
- Price Action: EBS shares are down 0.72% at $65.15 in market trading hours on the last check Wednesday.
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