Problems at Emergent BioSolutions Plant even worse

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):

  • Employees were involved in manufacturing steps of the vaccine of both clients without first changing clothes or showering as required
  • Leakages were not properly investigated
  • Used and contaminated equipment and waste were improperly handled and not controlled
  • Floors were damaged and rough, paint was peeling on some walls
  • Unknown contamination in some rooms
  • The warehouse was overcrowded and too small
  • The hygiene concept was not adhered to by individual staff members and SOPs were not followed
  • The flow of goods was criticised
  • Staff was not fully trained in CGMP and procedures.
  • Some of the equipment was unsuitable and not properly cleaned.

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