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FYI, FDA intends to begin routine inspections of Small Businesses under the FSMA Intentional Adulteration Rule in March 2021


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#1 TimG

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Posted 20 July 2020 - 03:56 PM

This came over my email from FDA today. Figured I'd pass it along for those who might have missed it.

If your email program has trouble displaying this email, view it as a web page.

 

Food Defense Updates
Food Defense at FDA is the effort to protect food from acts of intentional adulteration.
FDA intends to begin routine inspections of Small Businesses under the FSMA Intentional Adulteration Rule in March 2021
July 20, 2020
 
Last week, the U.S. Food and Drug Administration announced that routine inspections of small businesses to verify compliance with the FDA Food Safety Modernization Act’s (FSMAIntentional Adulteration (IA) rule will begin in March 2021. The compliance date for small businesses (those with fewer than 500 employees) is July 27, 2020. 
 
Recognizing the unique situation COVID-19 has created for both industry and regulators, the FDA intends to begin routine inspections of small businesses under the IA rule in March 2021. This approach, consistent with our approach regarding IA inspections of larger businesses, will help facilitate industry’s continuing efforts to put in place measures that will protect public health while allowing the FDA additional time to conduct outreach to stakeholders. 
 
For More Information

  



#2 SQFconsultant

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Posted 20 July 2020 - 05:29 PM

FDA has visited two of our clients during the past four weeks - both started at reception asking for the PCQI.


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#3 olenazh

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Posted 20 July 2020 - 05:40 PM

FDA has visited two of our clients during the past four weeks - both started at reception asking for the PCQI.

How sophisticated, PCQI, eh? Couldn't they simply ask for the QA?:)



#4 TimG

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Posted 20 July 2020 - 06:09 PM

How sophisticated, PCQI, eh? Couldn't they simply ask for the QA?:)

 

Most..no I take it back, ALL of the FDA inspectors I've had the honor of accompanying during a facility inspection have been extremely out of touch with how things in a manufacturing plant work. I wouldn't be surprised if a few of them have the notion that we've changed those QA job titles to 'PCQI.'


Edited by TimG, 20 July 2020 - 06:09 PM.


#5 olenazh

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Posted 20 July 2020 - 06:39 PM

Interesting: I knew that FDA's back to routine inspections (read on Food Safety News), but didn't hear of these specific ones RE: intentional adulteration. Though, I'm pretty sure Canada will copy whatever's US doing (as usually), but CFIA doesn't have emphasis on food fraud/intentional adulteration matter. 



#6 mgourley

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Posted 20 July 2020 - 09:52 PM

How sophisticated, PCQI, eh? Couldn't they simply ask for the QA?:)

 

No, because they are asking for a certificated Preventive Controls Qualified Individual.
If that happens to be your QA, no worries.

 

Marshall






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