14/15 June 2022
It is hard to believe what one can read in the Form 483 that the FDA issued to the Emergent BioSolutions site in Baltimore - the site that already had major problems last year during an FDA inspection and where there was a mix-up in the manufacture of Johnson & Johnson's (J&J) Covid-19 vaccine.
Workers at the contract manufacturer's site, where the AstraZeneca vaccine was also produced, had accidentally mixed up ingredients of the two vaccines. This affected 15 million vaccine units from J&J. Due to the problems, the company was inspected again by the FDA in April 2021. Now the observations made were published in a Form 483.
In this 13-page report, the inspectors criticised, among other things, the unclean and unsanitary conditions and an inappropriate size and layout of the operating rooms. Here are a few general observations (see the 483 for details):