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Anyone still getting harassed by the FDA over hand sanitizer?

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Were you ever inspected or audited by the FDA for your hand sanitizer production?

I thought the FDA harassment saga was long over, but it reared its ugly head again last week.

In December of 2020, the FDA selected me for a random inspection, audit, and sampling of my finished product. I provided them with all of the batch documentation that they requested. I was told by the inspector that I would hear shortly if there is an issue after analysis of my products but that no news was good news. Months went by... I heard nothing... until last Friday.

18 months after my inspection, over 2 years after my last production batch, and regardless that I deregistered, delisted, and sold out of my product last year, I received an email from FDA stating that they detected unacceptable levels of impurities in my sanitizer and a whole laundry list of actions I need to take. I've heard of a few others who have also been receiving notices this month so keep an eye out.

This is absolute insanity. The compound they are alleging was found was acetaldehyde, which is a naturally occurring byproduct of fermentation and forms when alcohol is oxidized or in the presence of acetic acid. I only ever used USP-grade GNS or food-grade grape alcohol - I wasn't adulterating it or doing sketchy things like others were so I'm scratching my head over how it's even out of compliance.

The sanitizer we were making was meant for short term consumption to help out in an emergency. If they stuck it in a hot government warehouse for 18 months I don't think it's unfathomable that the composition changed as the alcohol slightly degraded. We're talking about parts per million levels here.

I'm trying to gauge how widespread this is:

Were you ever audited by the FDA?

Did you ever hear anything back - good or bad?

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On 6/29/2022 at 1:19 PM, adamOVD said:

Sounds infuriating. We were never contacted. Hopefully you are in the minority.

It's pretty annoying and flies in the face of the promise the FDA made to not go after distilleries who were doing their best to do the right thing.

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