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EIRs Full Text!

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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:

• Preparing for your own inspections
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• And much more!

  

  

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descriptions of unpublished FDA FOIA records:

Popular searches include: drug trade or generic names; FDA investigator names, company names, device names or 510(k) numbers & more - see Search Hints for more ideas!

Your results may include Establishment Inspection Reports; Investigator Diaries; 483s; correspondence; 510(k)s (not just summaries!); meeting records;
drug, device & biologic original & supplemental reviews & more.


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. Please note that under the Freedom of Information Act, the FDA is required to remove certain information from documents prior to releasing them. Some types of documents, such as 510(k)s and PMAs, are more heavily redacted than others. Most redactions used on these documents fall under the (b)(4) and (b)(5) exemptions of the Freedom of Information Act. Contact us at infoFOI@foiservices.com for more information.


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