EIRs Full Text!Click here to search inspection documents FULL TEXT!
Searching is free.
You can already search the descriptions of all of FOI’s records…and now, you can search the full text of EIRs, 483s, FDA/Industry correspondence and other inspection-related content for revealing and hard to find information:
Enter your keyword(s) to search the
The Freedom of Information Act (FOIA) requires U.S. agencies to disclose many of their records. FDA's FOIA records usually aren't on the agency website – they're files from the desk drawers of reviewers, investigators, and other officials - and FOI Services has collected over 100,000 of these documents. Contact us at infoFOI@foiservices.com for more information.
Find a Document You Need?
Add it to your cart and download it immediately.
Want Some Advice?
Contact us...our information specialists can explain document
content, help you search, and answer other questions.
Can't Find Something?
Call us at +1-301-975-9400 to place a custom request.
This Government Accountability Office report was prepared in December 2017 to examine FDA medical device reviews specifically to evaluate if requests for additional information follow a least burdensome approach. The document describes FDA's requests to manufacturers for additional information, looks at FDA staff training in least burdensome requirements and describes the changes in procedures FDA has implemented to follow the least burdensome path.
Featured until March 27, 2018. Click here to download.