Is taking Photos by the Auditor during FDA Inspections allowed?

Aphel

Involved In Discussions
#1
Hello,

I have a short question regarding the rights of an FDA inspector... :confused:

Does an inspector have the authorisation by law to take photos of the facility, manufacturing sites,... during the inspection? If yes, which law?

Thanks very much.
Best regards,

Aphel
 
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A

amit_rd

#2
Re: Taking photos during inspections allowed?

Dear Aphel,

In my opinion, this question is very subjective and needs elaboration on which country and what type of photographs are you referring to? Generally the FDA inspectors are even allowed to take samples and in that case they would definitely be allowed to take photographs (my opinion). On the other hand few companies won't let you in with a camera citing reasons like security, confidentiality etc
 

Randy

Super Moderator
#3
Re: Taking photos during inspections allowed?

If you're in the USA the inspector has the right to bring in Rooster Cogburn, Matt Dillon and the full weight of the US Dept of Justice under Federal Court Order if necessary
 
M

MIREGMGR

#4
It's not very functional to attempt to deny an FDA inspector access to, or techniques for documenting his/her inspection of, your operations and facilities.

However, it can be interesting and useful for you to know the inspector's thinking. Did you ask the inspector his/her purpose for the photographs? It might be that the inspector is documenting something so as to show it to superiors or colleagues in order to decide how to make a judgment call. You might be able to provide additional relevant information that would improve understanding of the situation, leading to an inspection-determination that is more favorable to you.

Some people think that a polite-but-formally-adversarial relationship with an FDA inspector is appropriate, as if they are out to get you if at all possible. I don't agree with that viewpoint. I'd rather be cooperative, open and friendly, just as we are with our NB auditors and visiting customers. Time is money, and my experience is that friendly audits/inspections go faster.
 
P

pacspage

#5
The information for how FDA conducts its inspections is located in the FDA Investigations Operation Manual. The section on Photographs, how they may be used and the justification is located in Chapter 5 - Establishment Inspections (section 5.3.4).

Go to the FDA web site and search for "Investigations manual". The Investigations Operation Manual will provide details on how the FDA performs investigations from the FDA's point of view.

Another good reference may be chapter 3 of the Guide to International Inspections and Travel (Foreign Inspections) on the FDA website as well.

Since you are outside the United States, local laws may have to be taken into account for photographs, but then you may be performing a "refusal of inspection" and accept those consequences.

Good luck.

Eric F
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
The information for how FDA conducts its inspections is located in the FDA Investigations Operation Manual. The section on Photographs, how they may be used and the justification is located in Chapter 5 - Establishment Inspections (section 5.3.4).

Go to the FDA web site and search for "Investigations manual". The Investigations Operation Manual will provide details on how the FDA performs investigations from the FDA's point of view.

Another good reference may be chapter 3 of the Guide to International Inspections and Travel (Foreign Inspections) on the FDA website as well.

Since you are outside the United States, local laws may have to be taken into account for photographs, but then you may be performing a "refusal of inspection" and accept those consequences.

Good luck.

Eric F
Eric, welcome to The Cove and thank you for the very good contribution. Because of your limited number of posts, the system does not allow you to add hyperlinks. The FDA Investigations Operations Manual is available here. An excerpt of the manual concerning pictures reads:
Do not request permission from management to take photographs during an inspection. Take your camera into the firm and use it as necessary just as you use other inspectional equipment. If management objects to taking photographs, explain that photos are an integral part of an inspection and present an accurate picture of plant conditions. Advise management the U. S. Courts have held that photographs may lawfully be taken as part of an inspection.
 

Wes Bucey

Quite Involved in Discussions
#7
Sidney presents a more detailed affirmation of Randy's comment that the feds can essentially do what they want and the organization refuses at its peril - the FDA can shut down the outfit which obstructs an investigation.

The question an organization needs to pose itself is "What is our true objection to photos?" If you fear disclosing a trade secret, you can state that as an objection for the record and ask that individual photos be treated as such and not released to the public. If the photo is to document an observation that a practice is contrary to regulation, even trade secret is not a bar to the photo.

:topic:
I am aware some cultures and religions have proscriptions against photos of people. These can be raised as legitimate bars and the FDA inspector persuaded to frame the photo to avoid capturing images of individuals with such beliefs. (For the most part, this only extends to identifiable face shots.)
 
J

JaxQC

#8
“Advise management the U. S. Courts have held that photographs may lawfully be taken as part of an inspection.”

Half-truth. The specific case was "Dow Chemical v. United States”, 476 U.S. 227 (1986) (see 5.3.4.1 - In-Plant Photographs) and was in reference to aerial photographs by the EPA rather than In-Plant by the FDA.


One path is to disclaim upon entering the facility (sign) that photographs are not allowed, consistent for all visitors.
 
P

pacspage

#9
Besides the Inspections Manual and the Guide to International Inspections and Travel, you might wish to look at an article recently published by the Washington Legal Foundation on this topic (May 25, 2012).

Go to google, and search for "washington legal foundation fda on premises". The article is on the wlf . org website.

Eric F
 

Randy

Super Moderator
#10
You gotta ask some questions and one of them is:

"Is playing silly games over photographs worth the possibility of a Federal Court Order that could padlock the facility until a complete ceiling to floor inspection/investigation is completed to the satisfaction of the agency involved?"

I can remember serving search warrants and getting them taken care of in a hour or two, then again because of the "helpfullness" of the folks involved we wound up almost establishing residency and being ever so much more diligent in our investigation just to make sure nothing was overlooked in pursuit of "justice"
 
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