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FDA Inspections/Investigations

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Kellio

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Posted 02 August 2019 - 03:11 PM

Good day Everyone,

 

I know this question is being ask already but I have been out of the site for a while. 

 

Could anybody share the latest experiences with FDA Inspections/Investigations?  Just curious to see what are the main objectives.

 

I work in a Spice and Extract Operation and we had FDA/ State of Texas Observation visit but we were alerted of the "SWABATON" coming.

 

Any experiences you can share will greatly appreciated.

 

Glad to be back

K



Marshenko

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Posted 02 August 2019 - 03:14 PM

I had them in Tuesday and Wednesday actually.  No swabbing - they just wanted to observe processing/sanitation, look over FSPs, allergen management, training, and supplier approval documentation.



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bakeryscience

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Posted 02 August 2019 - 03:16 PM

They have never swabbed our facility before.



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Kellio

The Food Scientist

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Posted 03 August 2019 - 07:36 PM

I was at a company still new and right before I got there they informed me they did get a FDA visit for swabbing. They told me they took around 20 samples from different areas in the facility (different zones) and swabbed for Salmonella & Listeria. They simply want to test your EMP. 

 

This may help you:

 

http://foodsafety.me...lity-swabathon/


Everything in food is science. The only subjective part is when you eat it. - Alton Brown.


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jkoratich712

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Posted 01 October 2019 - 08:44 PM

We have a site that the FDA is currently at. They are wrapping up day 2 and are planning on returning tomorrow. No swabbing, but did reference their website for us to get an idea of what to expect. It can be found here: https://www.fda.gov/...mental-sampling .

 

We are seeing them dig through about 1.5 years of records - reviewing every entry, etc. They informed us that 'this is nothing' and we can expect a full week next time. Much different then their visit 2 years ago, which was only 1.5 days and was more risk based on how they approached documents and records. 

 

Much tougher this time around.





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