Category: quality intelligence

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.

Emergent FDA 483 from April 2020

Earlier in the week after reading the New York Times reports “U.S. Bet Big on Covid Vaccine Manufacturer Even as Problems Mounted” I commented that “This is a pretty damning report. Especially to the FDA for a failure of their inspection program if even half of it is true.”

Today John English pointed out the April 2020 FDA 483 for the Baltimore site of Emergent. And it is a doozy in six pages. Thank you FOIA.

Observation 1: Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel

This one is a real bellwether to me. The failure of the quality unit to ensure a robust computer system validation program was in place, to ensure data integrity. The fact that the three parts to the observation run the gamut from infrastructure to implementation to on-going use stands out that there are significant weaknesses in data integrity as an approach.

Observation 2: Established specifications, test procedures and laboratory control mechanisms are not followed and documented at the time of performance.

Well, forget about contemporaneous. Significant data integrity and culture failure here.

Part (b) indicates a failure to manage and track lab errors.

Also some concerns on chain of custody of samples are raised.

Observation 3: The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

This observation raises some significant questions in how they manage OOS investigations.

Observation 4: Employees are not given training in the particular operations they perform as part of their function and current good manufacturing practices

Build training plans, execute training plans, document training.

Observation 5: Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected components before disposition

It is like the FDA saw exactly what was going to happen and did nothing to stop it.

Thoughts

This 483 chilled me to the bones reading it. Major failures in quality here. The fact that this was in April of 2020 raises significant concerns in my mind about how Emergent got any contracts for vaccine delivery.

I have written to my congressional representatives demanding hearings. We need to know who made what decisions when. The trust in our regulatory regime requires full transparency and introspection.