Buying an FDA document vs filing a FOIA request
The short answer
File a FOIA request when you need FDA’s official release, or a record nobody else has, and can wait weeks or months: FDA has 10 business days just to log the request, and processing fees may apply. Buy the document when an inspection, audit or deal is on the calendar and you need it this week at a known price.
Two timelines
FOIA request
- File the request
- Logged (up to 10 business days)
- Processing, fees, review
- Records (weeks to months)
FDA Intel
- Search
- Download, minutes later
| FDA Intel | FOIA request to FDA | |
|---|---|---|
| Time to the document | Minutes | FDA has 10 business days to log the request; processing time varies |
| Cost | Fixed price shown before you buy | No fee to file; processing fees may apply, and FDA can ask for prepayment above a threshold |
| Know what you’ll get | Yes: firm, dates, investigator, page count and observation previews | No, until records are released |
| 483 vs EIR | Both available the same way | FDA says 483 requests are generally faster and cheaper than EIR requests |
| Official agency release | No | Yes |
FOIA facts from FDA’s Freedom of Information pages and FAQ, checked 31 October 2026.
Questions
How do I file a FOIA request with FDA?
FDA asks that requests be submitted online through its FOIA portal, describing the records you want as specifically as possible: firm name, FEI number and inspection dates help.
Is a FOIA request free?
There is no fee to file. FDA may charge processing fees and can require prepayment when the estimated cost is above a set threshold.
When does a FOIA request make sense?
When you need an official release from the agency, or a record nobody else has, and your timeline allows weeks or months.
When is buying the better choice?
When an inspection, audit or deal is on the calendar and you need the document this week, with a known price.
FDA Intel is independent and is not affiliated with or endorsed by the U.S. Food and Drug Administration. Also see all options compared and FDA Intel vs Redica Systems.