The Food and Drug Administration issued a scathing inspection report of the Emergent BioSolutions (EBS) facility where millions of doses of the Johnson & Johnson (JNJ) Covid-19 vaccine were contaminated, a development that set back plans to quickly vaccinate as many Americans as possible.

The 13-page report detailed nine serious violations at the Emergent plant in Baltimore, including failures to investigate instances of contamination, maintain sanitary conditions and sterile equipment, and follow procedures for preventing contamination. The FDA also cited personnel who were not well-trained, a poorly designed building, and the use of inadequate equipment.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!

GET STARTED

What is it?

STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What’s included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • STAT+ Conversations
  • Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.

Source: STATNEWS.COM

Leave a Reply

ArabicChinese (Simplified)EnglishFrenchGermanItalianJapanesePortugueseRussianSpanish

[mc4wp_form id="449"]