FDA Notification of FOI Expedite Request Denied Control # 2024-5142

I have appealed to the Office of the Executive Secretariat, US Food & Drug Administration

The title is from an email from FDA earlier today:

Expedite Request Denied Control # 2024-5142

This is my appeal letter, just sent:

Office of the Executive Secretariat

US Food & Drug Administration

5630 Fishers Lane, Room 1050

Rockville, MD 20857

FDA FOIA reference file: 2024-5142

Dear Office of the Executive Secretariat,

I am in contact with Ms. Sly in relation to the FOIA reference above. The information provided was not initially as requested, but during a telephone conversation with Ms. Sly, June 17, 2024, I agreed to accept a previously released Establishment Inspection Report (EIR) for the CBER pre-license inspection ending July 23, 2021, at the Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC (used to support the original approval of COMRINATY, BLA 125742) in fulfillment of CBERs portion of my request.

The support I received from Ms. Sly was excellent. However, I was puzzled as to why the pre-license inspection above was not on the FDA inspections database, shown below (accessed 05…