FDA has responded to my questions on a Manufacturing Facility Inspections FOIA—It's not Good News...
You've got to have lots of $$$$$s to pay for their work...
Subscribers may remember this potential bit of good news I reported recently:
I had been told by FOIA staff that the document I had submitted would be passed on to Quality staff at the Center for Biologics Evaluation and Research (CBER)
This is the reply that came in earlier today:
Good Morning,
I have received the subject FOIA request for the following:
“This FOI relates to the following Inspection at FEI Number 1222181, Wyeth BioPharma Division of Wyeth Pharmaceuticals: Inspection End Date: 09/19/2023 Inspection ID: 1218069 Product Type: Biologics Classification: VAI I wish to know what the voluntary action comprised and would like sight of the inspection report, if that were possible. Was there a further FDA inspection (biologics) to confirm that remediation activities in the VAI had been carried out satisfactorily? In relation to the inspection below: Inspection End Date: 04/28/2017 Inspection ID: 1020234 Product Type: Biologics Classification: VAI I wish to know what the voluntary act…