Today Janet Woodcock issued a statement “FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines” which links to the April 2021 Form 483 of the Baltimore facility.
- Failures to investigate deviations
- Failures for material management
- Failures for gowning
- Failures of the cleaning program
- Failures in facility design
- All around failure for contamination control
- Failure to have a comprehensive training program
I have requested hearings from my congressional representatives. The path where Emergent received so much money from the federal government to lead to this place is frightening.