Open letter to Dr Robert Califf, FDA Commissioner: Why were critical quality issues with Moderna boosters, identified by FDA inspectors, ignored?

Dynamite stuff!!!

This is the text of the Open Letter:

Dear Dr Califf,

This is an open letter in follow-up to a question I have submitted to the FDA’s Center for Biologics Evaluation and Research (CBER). The question is repeated below:

“Dear FDA,

My question relates to FDAs release of the Moderna booster vaccine, reported in a Fierce Pharma article dated September 21, 2022, titled:

Moderna’s new booster launch tripped up by production issues at Catalent plant: reports

This is a short excerpt:

On Tuesday night, the FDA released (PDF) a Form 483 notice it had sent to Catalent, citing 12 observations from a lengthy August inspection of its Bloomington, Indiana, site. The massive facility is among the largest in the portfolio of contract manufacturing powerhouse Catalent. Most of the observations had to do with quality control, record keeping and the failure to establish and follow procedures. The FDA noted a failure to address unexplained discrepancies in a batch of drug product (DP).

The detailed findings of hig…