Emergent Pledges FDA Improvements at Troubled Vaccine Plant (1)
By Riley Griffin and Anna Edney
June 14, 2021, 4:19 PM
Emergent BioSolutions Inc.is promising the Food and Drug Administration a series of fixes in response to an inspection that led to a halt in production at a company facility that had been making Johnson & Johnson’s Covid-19 vaccine.
The contract manufacturer said in a letter to the FDA dated April 30 that it would strengthen its biowaste handling processes, put in place new requirements for wearing protective gowns and deliver training to facility personnel, among other steps to ensure the quality of the vaccine, after agency inspectors cited myriad problems in a report earlier that month.