A dated FDA inspection report on one firm
For supplier qualification, an audit file or a deal: one firm's FDA inspection record, compiled and dated as a PDF.
How to order
- Find the firm with the search and open its record.
- Click Dated inspection report on this firm: the form below fills itself in. You can also type the name and FEI here.
- We compile the report by hand and send it to you as a PDF by e-mail, with a card payment link for $19. You pay after you have the report.
A dated report on this entity
The pages of this site are free and will stay free: an official fact belongs to no one. What is sold is the compilation work — what the public registers say about this entity on a given date, and what they do not say.
What the report contains
- every FDA inspection on file since fiscal year 2009: dates, classification (NAI, VAI, OAI), product type and project area
- every Form 483 observation the FDA posted: regulation cited and the investigator's wording
- compliance actions (warning letters, injunctions, seizures) and the documents the FDA published
- what was not found, written down: the files checked and the empty results
- the exact citation: FDA Data Dashboard files and their date
Price: $19 / firm (FEI)
What the report is NOT
It is not an FDA document, an audit or a certification. It states what the FDA Data Dashboard files show for this FEI on their date. A Form 483 is not a final agency determination, and an absence of posted citations is not proof that none were made.
This is an order form. The request reaches us and we confirm it by e-mail before any payment. Nothing is charged at this stage.
Have a whole list rather than one entity? See the professional access.
Not a consumer reporting agency. This site and the datasets sold from it are not consumer reports under the Fair Credit Reporting Act, and must not be used to decide anyone's eligibility for employment, credit, insurance, housing, or any other purpose covered by the FCRA. If you need a background check, use a screening company that operates as a consumer reporting agency.