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Is anyone getting FDA Inspections for their Hand Sanitizer?


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Here is Virginia the FDA reps have started calling distilleries and breweries who made hand sanitizer to ask them a "COVID-19 Questionnaire". For the ones who have done it so far they seem to focus on what precautions they took in social distancing, etc. during COVID-19. They then ask to visit the distillery and do a "follow-up" on site. They won't provide the phone interview questions ahead of time nor what they want to look at when they visit.
 
When they showed up there were no COVID-19 questions at all. They start asking for details of the audit trail on the ethanol used for the hand sanitizer from the "source to the bottle" with the paper trail. They end by asking to take away several bottles of hand sanitizer for "testing". The last one ended saying there woudl be no "feedback" on the visit and "no news is good news".
 
We're not worried about the formulation and although their "table manners" seem a bit rude we can understand the "I am an FDA investigator" ego.
 
I just wanted to see if anyone out there experienced this of if it is localized to Virginia. I not sure, given the temporary guidance, that the FDA really has the authority to function that way hence the "voluntary" participation.
 
We are putting together a "checklist" for local distilleries so they can be sure they have all their paperwork, etc. ready to reduce the disruption of operations as much as possible
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Just got one.  They almost forced us to recall.   The reason.... we have the SDS for the GNS we are using but they wanted us to keep batch records and have every batch analyzed by a lab.

So, they used us and now they are set to abuse us.

I just told staff to cease and desist and when people call in to ask for the product tell them they can thank their government for screwing them over.

Between the economic destruction from COVID orders, the continued restriction in state-to-state alcohol sales that are clearly in violation of the US constitution interstate commerce laws, and now this after the fact attacks on distilleries that tried to help (we donated over half of the hand sanitizer we made)... anyone feeling like they will benefit from political choices that increase the size of government?

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They called us the other day. I didn't speak to him much, he wanted to speak to the person that filed the FDA paperwork, which thankfully wasn't me. We made the alchohol in our sanitizer, and they just asked a few questions about proof, denaturing ect. No physical inspection, asking for samples for testing, or records. Knock on wood.

My guess is they are checking for excess methanol or fuel ethanol with crap in it. 

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I had an FDA inspection at the distillery I run and my experience was very similar to that of @Bob Morris and @Patio29Dadio . FDA came and inspected and wanted an requested an excessively exhaustive paper trail of production that simply did not exist. Our distillery as im sure most did, followed the guidelines published, but did not track every single last tiny detail. The inspector seemed unhappy about some things and took samples then left, saying they would get back to me with the test results. It has been 3 weeks and I have not seen anything back yet

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Are the people getting inspected currently producing or are there folks that have stop producing getting inspected? We only did a few barrels and stopped. Nothing here to inspect other than paperwork. I haven't heard anything other than a survey they sent us. No phone or emails.

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  • 2 weeks later...

They are coming back for a re-inspection.  Which tells me that we have too many FDA employees with not enough to do.  There are no politicians in my neck of the woods that will fight this fight... they are all made from the same cloth of big oppressive nanny government that are always here to help... right. 

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15 hours ago, Patio29Dadio said:

They are coming back for a re-inspection.  Which tells me that we have too many FDA employees with not enough to do.  There are no politicians in my neck of the woods that will fight this fight... they are all made from the same cloth of big oppressive nanny government that are always here to help... right. 

What exactly are they coming back to reinspect? We have an inspection today and luckily this agent and this thread have got us slightly prepared. Still worried about the nitpicking though

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