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Differences between FSMA, VQIP and FDA Audits

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Venkateshkini

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Posted 11 November 2022 - 07:34 AM

Can any on help me by elaborating differences between - USFDA Auidt, FSMA Audit, FSVP Audit and VQIP Audit. Also please tell me about FSPCA



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Kara S.

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Posted 11 November 2022 - 01:44 PM

US-FDA Audits - There are multiple types based on regulations. So this will overlap with FSMA audits. They will come on-site and say what they are there to inspect. Typically GMP is always included and then will focus on another part of the regulation. https://www.ecfr.gov...-I/subchapter-B

 

FDA Audits 

  • Juice HACCP - They will inspect you based on 21 CFR Part 120
  • Seafood HACCP -  21 CFR Part 123 
  • Infant Formula - 21 CFR Part 106
  • Dietary Supplements - 21 CFR Part 111

 

FSMA Audits (also conducted by FDA )

  • Preventive Control Inspection - They come in to ensure you are following 21 CFR Part 117. Will choose 1 product you are running that day and conduct their own ingredient hazard analysis to see if yours matches theirs. Label content will also be verified. The Inspector will go through your whole food safety plan and determine whether they believe your preventive controls are adequate. 
  • Foreign Supplier Verification Program (FSVP) They will inspection importers against 21 CFRW Part 1. FSVP is very similar to a Supply Chain program that would be used by food manufacturers in FSMA. 
  • Intentional Adulteration Rule  - This looks at 21 CFR Part 121 to ensure there is a Food Defense Plan. 

I do not know much about the VQIP

 

As for the FSPCA they are an organization that created training programs to assist with compliance to these FSMA related programs. They work closely with the FDA to create the curriculum. The training classes are one way to meet the FDA definition for Preventive Controls Qualified Individual (PCQI) and Food Defense Quality Individual (FDQI). The training classes will help you create food safety and food defense plans for your facility. They also have resources and a technical assistance network for you to use. 


Kind regards, 

 

Kara Scherer 

Food & Beverage Industry Consultant

LinkedIn  |  Webpage

 

 


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Venkateshkini

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Posted 16 November 2022 - 04:07 AM

Thanks a lot Kara . :smile: :smile:

 

The answer helped me a lot to undesratnd about those regulations





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