FDA Inspections and Pest Control - Pallets too close to walls

#11
I'm not one to pick a fight or argue endlessly with an auditor, but I am confident that "best practices" in one industry does not always translate to "best practices" in others (or else that industry would be subject to those standards from the onset). Does this infer that the food industry would then be expected to conform to specific best practices applied to Class I medical devices? This is the very reason why there are so many standards spread across so many industries.

Unless the auditor can site the standard that applies to the Class I medical device manufacturer being audited, I would dispute the NC to the head office and (if need be) request an auditor who is more familiar with the industry they are auditing.
I would agree to the point on the 'citation / traceability' of relevant standard + 'impact/intent of cited references towards pertinent requirements'
The point is, above cited points are pertinent and relevant for pest control procedures which are equally required by part 820 & part 211. ( and presumably both the standards do not explicity outline or reference above cited food-standards; atleast as of now its not found through search)

but extending the argument to base that as a reason to change/replace the auditor would look more like an legal-argument - because,, as long as the cited 'best practices' are relevant and pertinent to the said standard, its difficult to argue the best practices, in this case of for device(class-I) vs drug products etc;
 
#12
I'm not one to pick a fight or argue endlessly with an auditor, but I am confident that "best practices" in one industry does not always translate to "best practices" in others (or else that industry would be subject to those standards from the onset). Does this infer that the food industry would then be expected to conform to specific best practices applied to Class I medical devices? This is the very reason why there are so many standards spread across so many industries.

Unless the auditor can site the standard that applies to the Class I medical device manufacturer being audited, I would dispute the NC to the head office and (if need be) request an auditor who is more familiar with the industry they are auditing.

I agree, if it ever came up as an official observation I would respond that we meet all FDA requirements for a Class I medical device manufacturing site. Luckily it has only ever come up as comments rather than official observations, but the fact that it has been a recurring theme was making me uneasy.
 

Ajit Basrur

Staff member
Admin
#13
I agree, if it ever came up as an official observation I would respond that we meet all FDA requirements for a Class I medical device manufacturing site. Luckily it has only ever come up as comments rather than official observations, but the fact that it has been a recurring theme was making me uneasy.
I totally agree with your frustration. As an auditor myself and having experience across Pharma, Medical devices, Laboratories and Cosmetics, I often bring the "best practices" to my auditees as pure Recommendations and not finding. The regulations always tell "what" to do but its up to your organization to decide on the "how". Typically, organizations have a procedure that establishes the pest control program, conducts an assessment (for example, monthly or quarterly per the pest activity), maintains the effectiveness of the program and recommends revisions to correct potential problems. If your program is robust, you can defend your practices.

Refer an example of Sample Integrated Pest Management Plan http://www.ct.gov/deep/lib/deep/pesticides/ipm/ipm_plan_general_pest.pdf
 

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#14
Hi, I actually have some questions about this too! My question is, how often do we need to have pest control monitoring? I understand that the compliance clause for this is in ISO 13485:2016, section 6.3 and 6.4, and 21 CFR 820.70. But both clauses really only states that the company must have monitor periodically or at regular intervals. Is there a specific interval we need to do? for instance, monthly, quarterly, or bi-annually?
 
#15
The company I work for hires a third party to perform pest control and they come monthly to check the traps and refresh bait stations. I know there are individuals on this forum who know much more about the details of FDA regulations, but if the FDA specifically states "periodically" in the regulation, I doubt there is anything more specific elsewhere; they likely want facilities to pick a frequency based on their industry and the amount of pest activity.

If I were to recommend coming up with an interval of testing, I would say pick an interval that you can defend. For example, our facility is rural and is surrounded by corn/soybean fields, so a monthly inspection is definitely necessary in order to make sure we're avoiding field mice and other such pests. Pick an interval that makes sense for the amount of activity you tend to see at your location, document the interval in your procedure, and, if you want, maybe start off with a bit of trend analysis to make sure the time frame you picked is sufficient. Record the amount of activity that you're finding in your traps and if it isn't changing much between the intervals that you've chosen after a few years, you can back off the frequency (or, conversely, increase it if you're seeing empty bait stations or full trays in the bug lights).

I hope that's somewhat helpful!
 
#16
Thanks for the advice! Yeah, we have a 3rd party pest control service, and they do come in monthly for several years now. But since we haven't seen any pests/vermins for a long time, we're thinking about reducing the service down to bi-monthly or quarterly. I just wanted to get some clarification/guidance from everyone to see if there are any concrete compliance rules for the periodic inspections. Anyway, thanks for the advice Schkund!
 

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