Manufacturers are routinely requested for copies of their most recent EIRs, by both distributors and international regulatory agencies.
As Michael notes, a good distributor doesn't distribute "whatever." They check out the products and the manufacturer, including their regulatory history.
International regulatory agencies will request a manufacturer's most recent EIR because, unlike most jurisdictions around the world, US regulatory approval is not based on ISO certification, and FDA does not issue certificates of QSR compliance. The only way for a US manufacturer to document "QSR compliance" is to provide a recent EIR. If the EIR does not document "compliance," (ie, there were significant findings) then the EIR is provided with the follow-up documentation confirming that the findings were addressed.
Although I'm all for ISO 13485 certification, I don't think it would be appropriate for FDA issue certificates. People tend to take them as documentation of compliance for whatever period of time the certification is in effect, where, in reality, they are documentation of compliance only during the few days to a week of the inspection. I think people are more aware of this when they look at an EIR than when they look at an ISO certification process.
I have never seen anything in an EIR that would come anywhere close to allowing someone to reverse engineer one of the inspected company's products. In my experience, EIRs are relatively high level reports, without detailed descriptions of products or processes.
My experience is consistent with Michael's, that the FDA usually does a good job at redaction. However, I agree with JoAnne's prudent recommendation, that you provide the EIR yourself, so that you can redact it yourself, rather than leaving it to FDA. In addition to the reasons she cited, I think this is a poor use of FDA's time; I think both industry and consumers would be better served if those tax dollars were dedicated to review and oversight of products, rather than of reports. In addition, since it is the manufacturer's information, not the FDA's, I think that logically the manufacturer is far better qualified to redact it.
Julie Omohundro, RAC (US, GS)
Principal Regulatory Consultant
Class Three, LLC
Durham, North Carolina
julie@class3devices.com
Original Message:
Sent: 12-11-2014 12:45
From: Joanne Pelaschier
Subject: FDA Inspection Reports
Hi Joy,
Michael is giving good advice. You can take a look on a site like www.483sonline.com and see what the redacted 483s and EIRs look like.
While 483s and EIRs are public documents, unlike warning letters, they aren't posted in their entirety by FDA - they must either be requested of you, or requested via FOIA (Freedom Of Information Act). If you request one by FOIA, it is provided redacted, but the redaction is done by the government and not by you. Note that FOIA requests are public information, so by providing the report to the distributor, you shield them from having their FOIA request become public record.
If you were to provide one to your distributor, it will be up to you to do the redaction. So, by providing the report yourself, you are able to keep greater control of what you choose to redact. It is unlikely that in either case, there would be sufficient information left in an EIR or 483 for someone to reverse engineer your product.
One challenge that is not often discussed is the challenge faced by contract manufacturers/design houses that work with multiple clients. To protect the confidentiality of all our clients, we have to take care to redact all the product names (and other potentially identifying information) in such documents. Otherwise, if one customer requested them, they'd get information about the other customers, which could be problematic.
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Joanne Pelaschier Ph.d.,RAC,CQA
Quality Engineer
Stellartech Research
Milpitas CA
United States
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Original Message:
Sent: 12-10-2014 13:05
From: Michael Swit
Subject: FDA Inspection Reports
This is not unusual at all.
First, FDA inspection reports -- 483s and EIRs -- are public documents. Indeed, www.483sonline.com has a collection of over 3100 483s for drug and device firms.
Second, if I were a distributor and I was going to be selling your products, I would want to know what your regulatory history was and would require you provide those for at least the past five years and commit to providing them going forward.
To see my perspectives on this, see my recent presentation on the subject at http://www.fdacounsel.com/files/Swit_--_SDRAN-OCRA_Outsourcing_--_Legal_Issues_--_20141118.pdf
Finally, I have never see an FDA inspection report that revealed any information that could be used to reverse engineer a product. FDA is required by the FOI regulations to redact any confidential information and usually does a good job of doing so.
If I were your distributor and you did not provide me with inspection reports, I would be very skeptical of doing business with you.
______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
P: +1 619 744 2215
F: +1 619 923 2648
C +1 760 815 4762
maswit@duanemorris.com
Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.
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Original Message:
Sent: 12-10-2014 12:25
From: Joy Pelfrey
Subject: FDA Inspection Reports
We are working with our Distributor in Mexico to register our IVDs there. One thing they have requested is our most recent FDA inspection report. I have never been asked this for any other country registration, including China who asked for so much, i'm sure they are trying to reverse engineer our products. Anyways, I feel like this report is a confidential company document. Has anyone else been asked to provide their inspection reports or any thoughts or concerns about sharing it?
Thanks for the input!
Joy
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Joy Pelfrey
Norman OK
United States
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