FDA inspections

[Hokapsig]

Had another winery owner get a notice that their home based winery would be inspected by the FDA. If a winery has more than 11 employees, the winery must be registered with the FDA under the Bioterrorism Act. Fortunately, we have less than 11, and this over reaching regulation will keep wineries from hiring from more people.

Here's the link:
http://www.beveragelaw.com/booze-rules/2017/5/22/why-the-fda-is-inspecting-wineries

From my profession, any time a government inspector demands access, you can tell them to go get a search warrant. They will have to prove to the judge the reason for the warrant, and if you have a judge that is either pro-business or pro-small government, the warrant may not be granted. This regulation doesn't pass the sanity check for small wineries. What do you think???

 

[wxtrendsguy]

Actually the link above is only partially true. All commercial wineries no matter what size they are must register with the FDA. Then if you are small enough with less than 11 employees with 50% dtc sales you are exempt. However for the exemption you have to file an attestation that says you are exempt. Of course at the moment there is no approved form from the FDA to use for the attestation. It is still in comment and review....typical gov't!

As far as the advice of denying the inspector without a warrant, you better think twice about that one. Sure you can deny them access but they can also deny you of your license to operate.

 

[Stressbaby]

The "requirements" in the link look pretty reasonable to me...keep records, label your stuff, good sanitation, educate employees, keep the toxic stuff away from the wine.

I seriously doubt this regulation will prevent wineries from hiring if they have the need to do so.

 

[salcoco]

head a winery also had a inspector every year. made a list of violations came back in about two months to see if okay. never had a real problem. did not have 11 employees either.I think it is wise to have third party identify food violations in your winery. certainly better than making someone sick.

 

[Hokapsig]

Actually the link above is only partially true. All commercial wineries no matter what size they are must register with the FDA. Then if you are small enough with less than 11 employees with 50% dtc sales you are exempt. However for the exemption you have to file an attestation that says you are exempt. Of course at the moment there is no approved form from the FDA to use for the attestation. It is still in comment and review....typical gov't!

As far as the advice of denying the inspector without a warrant, you better think twice about that one. Sure you can deny them access but they can also deny you of your license to operate.

How can they deny a license to operate as I already have a license to operate and my license is not with them? My license is with the TTB and PLCB, not with the FDA. I'm not sure the jurisdiction from one agency can overrule another agency.

 

[wxtrendsguy]

Ah Hokapsig remember here in Pennsylvania the Pennsylvania Dept of Ag requires you to also have a permit along with the PLCB and TTB. The PA Dept of Ag has been prompted by the FDA to look at wineries as food facilities. I sat in a very informational meeting a few years ago with the PA Dept Of Ag chief who basically said of all the inspectors you may face as a winery owner the one performed by the PA Dept of Ag is the one most likely to shut down your operations...

I oversimplified my answer regarding the FDA and the ability to deny you a license. In this case its actually far more complex. The law in question is FSMA (Food Safety & Modernization Act) and enforcement of said law can result in: Advisory Letter, court actions such as an injunction or siezure, or other administrative actions of which there are several.

 

[HopsandVine]

How can they deny a license to operate as I already have a license to operate and my license is not with them? My license is with the TTB and PLCB, not with the FDA. I'm not sure the jurisdiction from one agency can overrule another agency.

I agree that the licenses/permits are generally not issued by FDA for wineries (with the exception of the FDA Food Facility Registration). FDA can suspend your FDA Food Facility Registration if they find you are not in compliance with FDA regulations. The regulations for wineries, though, are generally not as restrictive as they are for more traditional food manufacturers.

I have heard recently that FDA inspectors are showing up at wineries unannounced. In the past, it was not uncommon for FDA to outsource inspections to state agricultural agencies or similar, who would vary a lot in terms of their inspection standard. Now, though, it seems that actual FDA inspectors are visiting and they expect to see significant books and records.

 

[NorCal]

#memotoselfremindmetokeepthisasahobby

 

[Trevor7]

Working for a medical equipment manufacturer, I am oh-so-familiar with the FDA. We have a 3rd party come in and do audits just to keep us prepared should the FDA walk in. If you sell any wine, you come under the jurisdiction of the FDA (Wine is food, -yes?). If it's a hobby, nothing to worry about.

 

[Bobp]

Id say loook at the positives..for instance, our jams/jellies are being processed in the universities kitchen which is FDA inspected .....
Being produced in a FDA inspected facility is a selling point and allows you to obtain the little block for your lable that says FDA inspected.... not only is your product locally produced, but its clean and safe too....

 

[salcoco]

don't want the FDA inspection?what are you hiding? I for one felt that the inspection proved I had a safe product for my customers. Is that a bad thing?

 

[bstnh1]

FDA inspections may pick up health violations that might otherwise go unnoticed. I guarantee you that if a health violation makes someone who drinks your wine sick, the resulting lawsuit will make you wishing you had FDA inspectors in there 24/7.

 

[Breakinbonesben]

I worked for food production for a long time. I've had multiple health dept inspections and one place had a inspecter come every day we were in production. Here is how I never had any issues:
1. Calibrate your equipment. Do it the moment they step on the property and you see them coming. Make it look like you do it every day.
2. Follow them during the inspection. If they write a violation ask to see the exact violation. Many times inspectors have things they like to see but are actually not violations.
3. If there is a violation, fix it right away. If it is something you can fix before they leave, do it. A lot of times they won't write it up and have to come back.
4. Be nice.
5. Play music they hate. Having to listen to music they don't like will make them rush instead of taking their time and nitpicking.

This is what worked for me.

 

[Venatorscribe]

Arrange a nice morning tea or lunch. It doesn't need to be anything fancy. Sandwiches and fruit will work. Then sit down and have a yarn about the industry and their job.it eases any tension.

 

[user 36973]

In case anyone didn't scroll down on the recent FDA email you received, apparently you can now file an attestation for small wineries.

Also beginning October 1st, human food facilities that meet the definition of a "qualified facility" in part 117 and are subject to modified requirements of the preventive control rule will be able to submit the qualified facility attestation forms electronically via the Qualified Facility Attestation Module. For more information on qualified facility attestations, please visit https://www.fda.gov/Food/GuidanceRe...tion/QualifiedFacilityAttestation/default.htm.

 

[wxtrendsguy]

Thanks JG for the info, I did not scroll down. I have submitted my attestation...good lord their website is a typical governmental navigation mess.