FDA Inspection, anyone?

[JohninWV]

We received a call yesterday from our state health department informing us that they have been contracted by the FDA to perform an inspection on our facility. That inspection will take place the first week of March.

Our inspector admitted that this was the first time she had done an inspection on a distillery, but that she had done a couple on wineries. She asked for the following items in addition to a plant inspection.

1. Flow chart of our process (which I have amended from our TTB filing)

2. Recall procedures with distributor/sales contacts

3. COLAs

I put all of this together with a recipe, cip procedures, daily log, process notes and batch approval sheets.

For any of you all that have been through this, including wineries, I'd be very interested in hearing about the experience and possible pitfalls that haven't been covered. Has anyone had a FDA Inspection? It all seems a bit weird given the level of alcohol (always 40% ABV or more) we work with.

[Oregon Spirit Distillers]

I have had several inspections from the Department of Agriculture who governs us instead of the FDA. He had many of the same concerns; flow, recall batch records. The first time he came through he had us make several changes, all of which I thought were ridiculous. After our first year half the suggested changes appeared as good ideas. I don't like the inspection process but I always learn something and am a better facility as a result.

Brad Irwin,

Oregon Spirit Distillers

[Jedd Haas]

In Louisiana, the state Health Dept. inspects on behalf of the FDA as well.

[Ken]

Had not been aware of potential FDA inspection. Process Flow Charts not a problem. Cola obviously not a problem. Knowing what batch/bottling run went where not a problem. Having a formal document of a recall process is an issue. Time to hit google and put pen to paper.

[Mars]

I am not an expert in FDA inspections, but my Mom worked for the FDA for years.

From all of the stories she told me it seemed like the FDA will want to make sure that you have quality control procedures in place. The most important thing though is probably that you have done due diligence. If they know that you are trying to do your best but find a problem the worst that would probably happen is that they give you a warning letter. It gives you a chance to reply in a letter describing your corrective action. They will then come back a check later that you have followed your corrective action plan described in your reply to the FDA letter.

[JohninWV]

WOW, that was painful.

First, they tried to tell me that I wasn't registered with the state as a Food Manufacturer, which carries another $500 license/fee. I currently pay $1500/year for a license as a distillery.

Then the list of violations came saying I was required to abide by the FDA GMP (Good Manufacturing Practices).

Do you have a clean room for all of your bottling, including curtains that separate it completely from the production area? Do you have doors or windows in the clean/bottling room? Do you have anything in the bottling that is not part of the finished bottled product? Do all of your employees wear hair nets and beard guards?

Do you have a complaint file? It's required even if it's just an opinion on the taste. I'm sure Pepsi keeps one for the 500 million people that prefer Coke.

Do you have any unfinished wood in the distillery?

Do you have backflow preventers on every connection, including your spray down hoses? We have several back flow preventors on our water supply, just not on the mop sink and the hand sink.

This is craziness. I know we, as distilleries, are required to file the Bioterrorism stuff with the FDA and to update it...and we did that. But I haven't seen any regs for the other stuff mentioned above. The clean rooms are silly. Every brewery and distillery I've toured would be shut down tomorrow if they did this. Anyone have any insight into FDA regulations for distilleries? Can I be required to pay $500 to the state as a food manufacturer and another fee to the state as a distillery? It's like playing a game and not knowing the rules.

[Donutboy]

Hey John-

I was bottling wine last week at a winery here in WA state when someone from the FDA did a surprise visit. The owner of the winery had never had a visit by the FDA and this visit was unscheduled. I'm not sure about your agent but this one had done her homework and had a couple of pages of notes on the owner, the products, and the history of the facility. I asked the agent if she visited wineries and distilleries frequently and her response was that this is new and that Distilleries and Wineries are the lowest priority. This agent didn't know squat about the wine making process, a little bit about the bottling process, and in the end used her flash light to check for mouse poop. She told me that she had yet to visit a distillery but was going to start visiting them soon. Appreciate your continued coverage of this as we all could learn a thing or two and prepared. But like you said it's hard t play a game and not know the rules.

Good Luck

Roy

[Kristian]

Building my clean room tomorrow, or wait... cleaning my building tomorrow. Either option sounds like a lot of work.

I wish the FDA would ask half of those questions at the local slaughter house. Next time we hang out I'll tell you about the state inspector that tried to apply fed brewery regs when he visited, then he harassed us for a few months until I chatted with his supervisor and then nobody would meet with me but the harassment stopped. FUN!

[whiskeytango]

JohninWV

What ever happened with this?

[Charles@AEppelTreow]

We had an FDA inspection earlier this year. Our first. This is in addition to the annual Dept. of Ag (& Trade & Consumer Protection in WI) inspection, which usually doubles up as a contracted FDA inspection. The inspectors all have personal peeves they concentrate on, and often there are special topic issues they seem to get orders to look for that change every year.

The FDA inspection was a non-issue for us. I'd already prepped a recall plan using the state approved template (which I added to, as i thought it was incomplete - but the state insists on a certain structure). I officially have a complaints log in one of the site logbooks - never used. And have a general SIPOC (Sources, inputs, Processes, Outputs, Customers) flowchart that includes contact info for primary sources and customers - handy for the recall plan. I had also written up our material traceability and batch labeling procedures ahead of time.

We do have wood in part of our fermentation area - it's always been a 'watch' issue. It could become a concern, but for now we'll just watch it (for mold growth). 'For now' is up to twelve years.

The FDA inspector we had told me that previously they prioritized inspections by potential risk, which put wineries and distilleries at the bottom of the pile - and they never got to them. But the recent food safety 'improvement' laws mandate that they get out to EVERYONE - overriding their internal priorities. She said the biggest thing they are finding is that about half the businesses in their database are simply gone. No longer in operation.

[JohninWV]

Charles,

Being prepared was good work on your part...for the FDA inspection and for business in general, I imagine.

I was pretty upset when they left. I'm sure a great deal of it was my pride. We go through quite a bit of effort to make sure our processes are sound and our equipment is well maintained, clean, etc. Many of these issues were issues that I just wasn't aware of. Most of them have no relevance in a distillery, IMO, because of the product that we sell.

I was also upset with some of the infractions they pointed out, including like clean rooms for bottling. Nearly every winery, brewery, and distillery I see, including the big boys would violate most of these.

With all of that said, we addressed all of the issues we could. Some were simple fixes, some were not. But at least I feel like I'm compliant.

They have not done a follow-up inspection.

[whiskeytango]

Did you have to do a clean room for bottling?

[Natrat]

Our NCDA (North Carolina Department of Agriculture) inspector is ALSO our FDA inspector. He has come by each year as an NCDA inspector, but not yet done an FDA inspection.

As NCDA, he is mostly concerned with holes in walls, cracks, keeping the grain pallets away from the walls (we have a brewery and a distillery in the same structure...different buildings, technically) and anything that might let a pest near the grain. Totally useless, IMHO, since we boil the hell out of it before it becomes beer. He is always very interested in every step of the process, and I have to spend the entire day humoring him and essentially doing the tour from hell. He has not yet shown an interest in the distillery, but for some reason he needs to know the names of our distributors.

On his last inspection, he pointed out each thing he'd ding me for on the FDA side...of course, he wasn't doing that, so it was basically free advice. We use spray bottles with sanitizer in them, which are unlabeled. He hates that. Also, our building is an old brick structure, and he really really wants me to cover the brick with FRP, but the regs say a clear coat is fine as long as it's not porous. As for bottling, I carry an ATP detector, and swipe surfaces for him. Even though there is no door between the brewery and bottling, it is technically a different building so we pass.

I'm a bit concerned after reading the rest of this thread, though...our distillery has a ceiling made of bourbon barrel staves...and charcoaly bits rain down on everything

[JohninWV]

Damn, Natrat, that sounds awful.

Whiskeytango, we do not have a clean room. We do however have one of the cleanest rooms I've ever seen for bottling. It separated from the rest of the distiller and only contains bottling items (boxes, bottles, corks, etc) and the equipment. But they didn't seem to care.

[kkbodine]

Wines and spirits are not a food safety issue microbiologically so there is no good reason to apply the same rules as other bottling operations. Utter waste of enforcement effort... should be left at the bottom of the pile. The issue with wood in a winery or distillery has always amused and confused me... we often ferment and store in oak; which is ... wood. So are we expected to have perfectly washable surfaces everywhere surrounding a stack of wooden barrels? Our local Ag. inspector came once when we opened, mentioned and then ignored my lovely wooden beams, asked about my experience, signed the form, and left. Far too many people being poisoned on a daily basis by restaurants.

JohninWV I feel your pain on the extra $500 food license... we are lucky here and only have to pay another $50 or so.

Cheers,

Keith

[Blaum Bros. Distilling Co.]

Clean room!? Craziness....

[Josey]

^{I know with some federal agencies like OSHA you may request a warrant prior to allowing OSHA to inspect your facility. Does anyone know whether you may deny the FDA entry and require them to obtain a warrant? Given that it does not appear that the FDA issues citations with associated penalties upon first discovering non-compliant conditions like OSHA, do you believe that it would be best to allow entry even if you have the authority to request a warrant?}

[bradocaster]

We had a surprise visit from an FDA inspector last week. She was very nice. she had done some homework, and had a reasonably business friendly outlook. She had just toured some big distilleries, and thought we were in good shape. she found some unlabeled drums, and our sanitize sprayer label had been washed off. It was freaky, but ended without incident. i expect more and more regulation, and inspections to come.

[bluestar]

We had a surprise visit from an FDA inspector last week. She was very nice. she had done some homework, and had a reasonably business friendly outlook. She had just toured some big distilleries, and thought we were in good shape. she found some unlabeled drums, and our sanitize sprayer label had been washed off. It was freaky, but ended without incident. i expect more and more regulation, and inspections to come.

Did you have a clean room for bottling? Did that come up?

[bradocaster]

It did not come up. we haven't bottled anything yet, so it may not have come up because she didn't see any filling equip, or full bottles. I guess we'll see..

[Hope Springs Distillery]

We had visited distilleries all over our state, and observed some unusual trappings only at the newest one - a three section sink for dish washing, a mop sink and a hand washing sink (yes - count 'em FIVE) plus what appeared to be vinyl covered walls for easy "wipe down", all of which were said to be Department of Agriculture requirements. I spent several days calling around the state Agriculture offices and no one seemed to know of any such requirements, which we had been told were categorized under the "Food Preparation" category. I finally found someone that said definitely yes, we need to be inspected and licensed, $500 a year. We're figuring this will all add yet another several thousand bucks that we may not be able to afford and had heard zero about in countless classes and seminars and such.

[JCNJDistiller]

On 2/17/2013 at 8:20 AM, Mars said:

From all of the stories she told me it seemed like the FDA will want to make sure that you have quality control procedures in place.

Does anyone have a formal write-up of their quality control procedures?