We all need to keep in mind that the FDASIA provision about "limiting" inspection applies solely to drug companies and not to any other-FDA regulated entity. Thus, the related guidance, to the extent it tries to bootstrap refusing to allow photos as a "limitation" on inspection, is only arguably of concern to drug companies.
Glen is right that the general question on photographing is a bit unsettled, but the two cases cited by FDA are far from supportive of the agency's position. However, there are some that would assert that FDA does have the power inherently. And, from a practical matter, if FDA really wants to take photos, they can go get a warrant to do so, which would then change the situation markedly.
Best,
Michael
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Michael A. Swit, Esq.
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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: 07-30-2013 16:05
From: Glen Freiberg
Subject: Delaying, denying or limiting an FDA inspection
Another aspect of this guidance is FDA slipping in the photography justification. Refusal for photography is not an inspection refusal. While FDA gives limited examples of why photos would be helpful, the argument about allowing companies to exclude photography as part of company policy - as far as I know - is NOT settled. FDA believes they have the right, but the cases they have historically cited are not applicable. In fact, they are a big stretch. This document may be their way to help intimidate some to allow any photos they desire.
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Glen Freiberg RAC
President
Rancho Santa Fe CA
United States
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Original Message:
Sent: 07-29-2013 10:01
From: Jan Peterson
Subject: Delaying, denying or limiting an FDA inspection
I do not consider it a suprise that FDA has never had to wait for a (new) Guidance Document to apply their interpretation of a regulatory authority to conduct inspections, and these issues about delays or misdirections, which are interpreted in effect as a kind of "refusal" activity, have been covered in the Establishment Inspections Operations Manual (IOM), Chapter 5 (section 5.2.5), for years. Clarification in a Guidance Document is almost always useful, but this added no new authorities. It seems the WL language appears relatively new, but not the activity which is being addressed (see picture attached, I hope it is displayed properly). And while there was no implication of an escalating problem here, it is still a crime to "...resist, oppose, impede, intimidate, or interfere with, a federal official in the performance of their official duties."
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Jan S. Peterson, MS, CCRA, RAC, MICR
Director, Regulatory Affairs
The EMMES Corp
Rockville MD
United States
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Original Message:
Sent: 07-27-2013 11:36
From: Andrea Chamblee
Subject: Delaying, denying or limiting an FDA inspection
FDA issues first waning letter specifically for Delaying, Denying or Limiting an Inspection.
Have you experienced anything like this?
The WL is dated July 18: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm361928.htm
The Guidance has just come out July 12: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM360484.pdf
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Andrea Chamblee RAC, FRAPS
Silver Spring MD
United States
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