UNITED STATES (KBJR)-- An FDA memo that surfaced Friday outlines how an estimated 75-million doses of the J&J vaccine were rendered unusable.
Inspectors at the emergent Biosolutions facility cited crowded manufacturing areas, inadequate quality assurance, and lab controls as problems.
In February, the FDA rejected an estimated 60-million doses of the Johnson and Johnson single-dose vaccine after a review of the Baltimore facility.
Then in March, the New York Times reported that another 15-million vaccine doses were ruined by quality control issues identified by J and J.
As of last week, the FDA has now approved 10-million doses of the single-dose vaccine from the facility as being safe to use.
Going forward, J&J must continue to share all relevant manufacturing information with regulators from both the u-s and countries where the vaccine may be used.