Emergent shakeups

Shakeups at Emergent

There is a lot to understand in this story. As congressional hearings unfold, and the shareholder lawsuit works the way through the courts, I hope we learn more about the how’s and the why’s.

Latest Emergent News

Today Janet Woodcock issued a statement “FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines” which links to the April 2021 Form 483 of the Baltimore facility.

  • Failures to investigate deviations
  • Failures for material management
  • Failures for gowning
  • Failures of the cleaning program
  • Failures in facility design
  • All around failure for contamination control
  • Failure to have a comprehensive training program

I have requested hearings from my congressional representatives. The path where Emergent received so much money from the federal government to lead to this place is frightening.

Emergent suspends manufacturing in Baltimore

“We recognize the confusion these recent events may have caused our customers, our employees, and the public,” Emergent said in its statement. “We acknowledge that there are improvements we must make … to restore confidence in our quality systems and manufacturing processes.”

FiercePharma “FDA orders shutdown at Emergent’s troubled plant 2 weeks after handing J&J the keys” April 19, 2021

What you never want to see in the press.

Emergent needs to overcompensate to restore confidence here and hopefully are bringing in the resources on the level of consent decree mitigation.

A Titanic Mix-Up — What’s HuP?

We’ve all seen by now the latest NYT reporting about Emergent and the mix-up that cost between 13 and 15 million doses of the J&J Covid-19 vaccine. As a human performance practitioner, my hair lit on fire when reading this statement: “An investigation is now underway, but federal and former company officials suspect the lot […]

A Titanic Mix-Up — What’s HuP?

My friend and colleague Dakota Stad writes on what recent reporting tells us about Emergent’s culture. Dakota’s points are spot-on – these issues start with senior leadership and are not on indicative of any sort of “rogue actors”.

It would be an easy narrative to blame the workers, but as always we should stay focused on building a just culture.