FDA inspections

Discussion in 'Commercial Winery Forum' started by Hokapsig, Jan 14, 2018.

  1. Hokapsig

    Hokapsig Senior Member

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    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???
     
  2. wxtrendsguy

    wxtrendsguy Member

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    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.
     
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  3. Stressbaby

    Stressbaby Just a Member Supporting Member

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    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.
     
  4. salcoco

    salcoco Veteran Wine Maker Supporting Member

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    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.
     
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  5. Hokapsig

    Hokapsig Senior Member

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    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.
     
  6. wxtrendsguy

    wxtrendsguy Member

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    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.
     

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