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.