Jump to content

Is anyone getting FDA Inspections for their Hand Sanitizer?


Recommended Posts

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
Link to post
Share on other sites

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?

Link to post
Share on other sites

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. 

Link to post
Share on other sites

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

Link to post
Share on other sites

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.

Link to post
Share on other sites
  • 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. 

Link to post
Share on other sites
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

Link to post
Share on other sites

Here is where we are...

They want certificate of analysis for all ingredients or else for each batch.   We talked them out of needing one for the isopropyl alcohol we use for denaturing because the SDS includes a paragraph that is enough of an analysis (basically they are needing proof that there is not too much methanol in the final product).

You can only use the exact products in the recipe that the FDA allows.  For example, we wanted to use inhibited proplylene glycol instead of glycerin/glycerol as we have a good supply of the former... they said a resounding NO!  

Need to have the process well documented.

Need to demonstrate accurate proof measuring.

They want batch records.  The containers need the batch number on the label.

Have to be registered with the FDA for the product.  The registration number (LABELER CODE needs to be on the label.)   This takes a few weeks.

I am in California... the land of regulating everything.

Link to post
Share on other sites
On 10/26/2020 at 4:26 PM, Patio29Dadio said:

Here is where we are...

They want certificate of analysis for all ingredients or else for each batch.   We talked them out of needing one for the isopropyl alcohol we use for denaturing because the SDS includes a paragraph that is enough of an analysis (basically they are needing proof that there is not too much methanol in the final product).

You can only use the exact products in the recipe that the FDA allows.  For example, we wanted to use inhibited proplylene glycol instead of glycerin/glycerol as we have a good supply of the former... they said a resounding NO!  

Need to have the process well documented.

Need to demonstrate accurate proof measuring.

They want batch records.  The containers need the batch number on the label.

Have to be registered with the FDA for the product.  The registration number (LABELER CODE needs to be on the label.)   This takes a few weeks.

I am in California... the land of regulating everything.

Oh wow, yeah your FDA inspector was way more hardcore than ours. Ours basically only cared about our last batch (we haven't produced any sanitizer in weeks, if not months, what month is it again?). Our label had just the required info, nothing like batch numbers or FDA registration numbers. That would make operations nearly impossible. They did want a papertrail for every ingredient going into the sanitizer and took some for testing but mentioned nothing about lab testing every batch which has been mentioned here. Guess all government agencies are alike huh? Depends on the agent you get what kind of hurdles you have to jump.

Link to post
Share on other sites
  • 1 month later...

Glad (?) to hear others are having the same experience. Last week I received a call from an FDA inspector asking quite a few specific questions about my hand sanitizer production: how much did I make, what formula did I use, what packaging did I use, did I sell it out of state, etc. I politely answered his questions and asked him why he's contacting me - was there a complaint? He assured me there wasn't a complaint - they were randomly selecting distilleries to audit. He asked me to email him the records of my most recent batch (including the POs, BOLs, and COAs of the ingredients I used), sales invoices and BOLs, and labels. Fortunately I kept pretty good records of everything. He said he has been auditing a lot of distilleries but strangely he did not know what Bitrex is or what a TIB is. I also found it strange that he asked me for my labels considering I had already uploaded them to the FDA database when I registered. He asked if he could conduct a site visit the next day. I told him I was way too busy working to comply with a new state shutdown on my business and we scheduled a meeting the next week.

My inspection was today. It took half an hour. He just had me sign an affidavit stating that the documents I gave him were true, collected 5 bottles for samples, and left. I asked him if I would be hearing about the results of the audit/samples whether they're good or bad and he said that's a good question. 

I notice some of you were contacted September or earlier - did anyone hear back? How long did it take? Did you pass with flying colors or did they come back at you with errors in your paperwork or contaminants in your sample?

I agree with @Bob Morris and @Patio29Dadio's sentiment... knowing full well that distillers have no experience manufacturing medical drugs, the FDA granted us emergency authority to produce sanitizer during a time of dire need. Now that we're not needed anymore they're auditing us and expecting our records to be perfect? All while we're struggling to keep our businesses afloat during a second round of state-mandated business closures? The tone deafness is astounding. I understand the need to protect the public. There are some bad actors that need to be reprimanded. I would be more understanding if they were operating on a complaint-basis or taking random field samples but this random audit method right now is pretty burdensome. Many of us busted our asses to come to the rescue of our community and this is how we're being thanked. No good deed goes unpunished.

We generated a lot of goodwill in our communities. We have the public on our side. The few people I've told about this are appalled that the FDA would conduct themselves in this manner. I'm hoping it was just a relatively brief inconvenience and we won't hear from them again. But if they decide to go further I think it's important that we all band together and generate quite the PR backlash. Let's keep each other updated.

Link to post
Share on other sites

We are about to begin production in our distillery within the next 3-6 weeks and the only thing I have heard from the FDA about was my biannual renewal for the FDA license.  We have been ABC cleared and look to be producing very soon.  I suspect Calwaise above has hit the nail on the head with his acceptation of the government's motives.  Emergency leniency to produce hand sanitizer only to come back after the fact and demand records and samples.  Just like you said, when you're not needed anymore you become a liability that they need to inspect for "errors".  

I don't think we will immediately be producing sanitizer but who knows what 2021 will bring us.  

I agree we should band together and I'd be willing to create a database of documents for VA distilleries from inspections, phone calls, etc so help each other out.  If there is any interested parties, let me know and I can get us some cloud space for sharing.  


Tim

Link to post
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now
×
×
  • Create New...