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CalwiseSpirits last won the day on December 31 2020

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  1. Thank you for explaining that. It makes sense. I should have known. Is sulfuric acid ok to use in distillation? Won't it decompose and form some nasty byproducts?
  2. Thanks for the info. On Friday I actually tried an experiment related to this. I added a bit of dunder to a spirit run - great results, ended up with desirably funky distillate. On the next spirit run, I added dunder and citric acid. My theory was that citric acid would aid in Fischer esterification and magnify the flavors I achieved during the previous run. Nope. I found it destroyed the good esters I was trying to make and instead I got relatively neutral hearts and ended up with tails that tasted bitter and horrible. It tastes like some sort of salicylate (menthol/wintergreen) ester was formed as well. Yep, I've noticed it in my whiskey too. Isoamyl acetate (banana) in particular - which I don't necessarily want a ton of in my whiskey - but I want it in my rum and I can't get it to stick around! I used to make very conservative cuts. Now if I'm making spirit that I plan on ageing, I'm going really deep into the tails. I'm starting to find going deep on the heads yields good results as well - as long as there isn't too much ethyl acetate.
  3. I've been experimenting with creating a super funky high-ester rum. However, I've been noticing that the esters degrade over time when it's barrel aged. I also made a Navy strength high ester rum and noticed that the esters degraded significantly after sitting in the bottle for a few months to the point where it was unrecognizable. Is there a way to stabilize the esters in finished spirit? My best guess is to add a little bit of acid (citric?) to the spirit but I'm not sure.
  4. I've had this happen before too. My best guess is sulfur.
  5. In my defense, I do know people who were purchasing organic GNS to make hand sanitizer because it was all they could find at the beginning of the pandemic. Crazy. I'm still sitting on a few thousand bottles I'm trying to figure out what to do with. Better than 10 totes though!
  6. We make cocktail syrups at my distillery in addition to spirits. We've been using a 5 gallon brew kettle on an induction plate to heat our syrups and then bottle them through a small ball valve. We fill 8oz bottles and use plastisol-lined screw caps. I need a larger more robust set up, about 25 gallons. I'm thinking ideally we'd use an electric jacketed kettle with a small ball valve with a nozzle that can fill a bottle with a 28mm opening. Does anyone else make syrups and have some equipment or production tips they can give me? TIA!
  7. Thank you! Their prices are almost 2x of what I was paying at Ultrapure 😬
  8. On a similar note, I'm looking for organic GNS. I usually get it from Ultrapure but they are having a hard time keeping it in stock. Any other recommendations?
  9. This whole thing is so asinine... My attorney contacted the FDA and this is the step-by-step email they sent: 1) The first thing you will want to do is delist the drug product. To do this: 1) Login to the CDER Direct Account (https://direct.fda.gov) 2) Click on “Product Listing and Reporting” 3) Click on “Submission Accepted” for the most recently, previously submitted Product Listing 4) Click on “Create New Version” (do not alter any of the information in the Header Details as it is correctly updated for you when you click “Create New Version”) 5) Click on the edit tool (pencil/notepad) next to the Product NDC toward the bottom of the page 6) Change the Marketing Status from “ACTIVE” to “COMPLETED” 7) Enter an End Marketing Date that corresponds to the last lot expiration date 😎 Click on “Save Product” 9) Click on “Submit SPL” 2) After that submission returns as “Submission Accepted” (takes about 15 minutes), then you may De-Register your establishment. To do this: 1) Login to your CDER Direct Account 2) Click on “Establishment Registration” 3) Click on “Submission Accepted” for the most recently submitted Establishment Registration 4) Click on “Create New Version” (do not alter any of the information in the Header Details as it is correctly updated for you when you click “Create New Version”) 5) Change the Document Type to “Establishment De-Registration” 6) Click on “Submit SPL”
  10. When I was audited a few weeks ago my inspector told me that the FDA was considering implementing a fee, but I got impression that it was going to be on future batches, not retroactive. I did find it interesting that part of his report was the value of the sanitizer I manufactured as well as the value of my current inventory on hand. If we are retroactively charged a facility fee, we need to create a substantial PR backlash. I'm already pissed off that they chose to audit us during the second wave of the pandemic. There were a lot of folk who didn't even bother registering with the FDA - they won't have to deal with an audit nor pay any fees. We're getting punished for doing the right thing. This is so egregious that part of me believes there's no way this is actually going to happen.
  11. 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.
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