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We got inspected by the FDA


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This is a first in 16 years of operations.

As far as we understood, DSP licenses are not regulated by the FDA. Does anyone have any documentation that says one way or the other?

We do have an FDA number, because we bring in yeast for the fermentation of molasses and fruit brandies, but as i mentioned, this is the first time in 16 years that we've been inspected.

Has anyone else been bothered by FDA?

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HUH.. so after some research.. i found this.

Memorandum of Understanding Between the Food and Drug Administration and the Bureau of Alcohol, Tobacco and Firearms

I. PURPOSE

This agreement between the Food and Drug Administration (FDA) and the Bureau of Alcohol, Tobacco and Firearms (ATF) is to clarify and to delineate the enforcement responsibilities of each agency with respect to alcoholic beverages considered adulterated under the Federal Food, Drug, and Cosmetic Act of 1938, and for other related purposes. Specifically, this Memorandum of Understanding will:

(A) Effect a more efficient system of communication and exchange between FDA and ATF;

(B) Confirm ATF policy with respect to the labeling of ingredients and substances in alcoholic beverages that pose a public health problem; and

© Clarify and coordinate the responsibilities of each agency with respect to the identification, testing, and recall of adulterated alcoholic beverages.

II. BACKGROUND

A. Pursuant to the Federal Food, Drug and Cosmetic Act of 1938, as amended (FD&C Act), 21 U.S.C. §§ 301, et seq., FDA has authority, inter alia, to take action with respect to adulterated food products, including alcoholic beverages, both domestic and imported. Among other things, a food is adulterated under section 402 of the FD&C Act if it was produced, packed, or held under insanitary conditions; if it contains any poisonous or deleterious substance which may render the food injurious to health; or if it contains an unapproved food additive. FDA has authority to initiate seizure of adulterated foods, including alcoholic beverages, and to seek to enjoin the introduction of such products into interstate commerce. The FD&C Act also authorizes FDA to refuse entry of imported products that appear to be adulterated and misbranded.

B. Pursuant to the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. §§ 201, et seq. and the Internal Revenue Code of 1986 (IRC), Title 26, U.S.C., ATF has authority over distilled spirits, wines, and malt beverage products, both domestic and imported. In particular, section 5 of the FAA Act (27 U.S.C. § 205) vests ATF with the authority to promulgate regulations regarding the labeling and advertising of alcoholic beverages to insure that they provide the consumer with adequate information concerning the identity and quality of such products. Section 5(e) also makes it unlawful to sell or ship or deliver for sale or shipment, or otherwise introduce into interstate or foreign commerce, or to receive therein, or to remove from customs custody for consumption, any distilled spirits, wine, or malt beverages in bottles, unless such products are bottled, packaged, and labeled in conformity with regulations prescribed by the Secretary of the Treasury. ATF is charged with the administration and enforcement of the FAA

Act and does this through, inter alia, the issuance of permits and through procedures that require the prior approval of all labels. In addition, ATF is charged with the administration and enforcement of Chapter 51 of the IRC, relating to Distilled Spirits, Wines and Beer. This chapter in conjunction with the FAA Act establishes a comprehensive system of controls of alcoholic beverages, including on-site inspections and procedures that require the advance approval of statements of process and of formulas showing each ingredient to be used in the product. The IRC also vests authority in ATF to detain any container that will be removed in violation of law (26 U.S.C. § 5311) and vests ATF with seizure and forfeiture authority (26 U.S.C. § 7302).

III. AGREEMENT

It is understood and agreed between the parties, as follows:

(A) ATF will be responsible for the promulgation and enforcement of regulations with respect to the labeling of distilled spirits, wine, and malt beverages pursuant to the FAA Act. When FDA has determined that the presence of an ingredient in food products, including alcoholic beverages, poses a recognized public health problem, and that the ingredient or substance must be identified on a food product label, ATF will initiate rulemaking proceedings to promulgate labeling regulations for alcoholic beverages consistent with ATF's health policy with respect to alcoholic beverages. ATF and FDA will consult on a regular basis concerning the propriety of promulgating regulations concerning the labeling of other ingredients and substances for alcoholic beverages.

(B) FDA will, upon ATF's request, provide ATF with a health hazard evaluation with respect to any substance found in alcoholic beverages. ATF agrees to provide FDA with any data or analyses it may have with respect to the substance in question.

© ATF will be responsible for testing alcoholic beverages to determine the extent of an adulteration problem. To the extent practicable, FDA will provide laboratory assistance at the request of ATF.

(D) ATF will prepare, in consultation with FDA, comprehensive formal procedures and guidelines for implementing voluntary recalls of adulterated alcoholic beverages. These procedures and guidelines will be developed in light of the FDA procedures and guidelines for such recalls and shall be implemented by ATF after review and comment by FDA.

(E) ATF, as the agency with a system of specific statutory and regulatory controls over alcoholic beverages, will have primary responsibility for issuing recall notices and monitoring voluntary recalls of alcoholic beverages that are adulterated under FDA law or mislabeled under the FAA Act by reason of being adulterated. This agreement does not affect or otherwise attempt to restrict the seizure or other statutory and regulatory authorities of the respective agencies.

(F) When FDA learns or is advised that an alcoholic beverage is or may be adulterated, FDA will contact ATF.

(G) When ATF learns or is advised that an alcoholic beverage is or may be adulterated, ATF will consult with FDA before it takes any action with respect to a notice of recall for the product. FDA, in turn, will expeditiously provide ATF with a written health hazard evaluation of each product involved in a recall situation or potential recall situation. ATF will provide FDA with any data or analyses it may have with respect to the product in question to assist FDA in undertaking a health hazard evaluation. Upon receipt of a FDA health hazard evaluation indicating a definitive hazard, ATF will advise the responsible firm as to an appropriate course of action which might include a voluntary recall.

(H) In situations involving a recall notice of an adulterated alcoholic beverage, ATF will advise FDA of how ATF intends to proceed and will keep FDA apprised of developments with respect to such recall.

(I) In situations involving a recall of an adulterated alcoholic beverage that poses a significant risk to the public health, ATF will consult with FDA before issuing any press release. Press releases will be issued in accordance with established ATF procedures and guidelines.

(J) FDA and ATF laboratories will continue to exchange information concerning methodologies and techniques for testing alcoholic beverages.

(K) FDA and ATF will continue to exchange a wide variety of information, including relevant consumer complaints concerning the adulteration of alcoholic beverages.

IV. PARTIES TO AGREEMENT

The parties to this agreement are:

The Bureau of Alcohol, Tobacco and Firearms
Department of the Treasury
1200 Pennsylvania Avenue, N.W.
Washington, DC 20226

and

The Food and Drug Administration
Department of Health and Human
Services 200 C Street, S.W.
Washington, DC 20204

V. DURATION OF AGREEMENT

This agreement becomes effective upon acceptance by both parties and shall remain in effect indefinitely. This agreement may be modified by mutual consent or terminated by either party upon a thirty (30) day advance written notice to the other.

VI. LIASON OFFICERS

For ATF: Norris L. Alford
Chief, Special Progress Branch
Bureau of Alcohol, Tobacco and Firearms
Washington, DC 20226
Telephone Number: (202) 566-7569

For FDA: Curtis E. Coker, Jr.
Division of Regulatory Guidance
Center for Food Safety and Applied Nutrition Food and
Drug Administration
Washington, DC 20204
Telephone Number: (202) 485-0024

Approved and Accepted for the Bureau of Alcohol, Tobacco and Firearms
Signed by: William T. Drake
Acting Director
Bureau of Alcohol, Tobacco and Firearms
Date: November 20, 1987

Approved and Accepted for the Food and Drug Administration
Signed by: Frank E. Young Commissioner of Food and Drugs Food and Drug Administration
Date: November 20, 1987

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I think that John Little @ Smooth Ambler had someone from the FDA show up at his door.

I was working at a winery here in Washington a few years ago and the FDA showed up flashing a badge....legit and a pain in the ass inspection.

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so after 3 hrs, and detailed description of what we are doing at our shop... the Major (they're a branch of the armed services???) determined that we are of such little "risk"... that we could be removed from their inspection list... so thats good... one less inspection to worry about.. .but in 16 years of operations, this is the first we've ever heard from the FDA... who knew?

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This past fall we were sorta inspected by the fda - via a contracted employee from the Colorado Department of Environmental Health and Sustainability. The inspector was poking around and asking questions for a solid 3 hours. In the end she requested that we not leave any hoses on the floor and that we remove the duct tape from the connection point between our flex auger and our mill.

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This past fall we were sorta inspected by the fda - via a contracted employee from the Colorado Department of Environmental Health and Sustainability. The inspector was poking around and asking questions for a solid 3 hours. In the end she requested that we not leave any hoses on the floor and that we remove the duct tape from the connection point between our flex auger and our mill.

Hoses on the floor could be a trip hazard but why would she ask for the duct tape be removed?

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They came in and spent about 3 hours with us. They found a few violations that we have corrected and that are better for but they were also silly about a few items.

1. We had a drain pipe all the way in the drain as opposed to being suspended. They were afraid sewage would back feed in the event of a sewer failure. Ridiculous. Could never happen but we corrected it anyway.

2. They wanted light covers on all florescent lights. We did this and it was smart.

3. We had exposed wood on the edge of a workbench and on one window. The said that was a bacteria hazard. We painted it.

4. The craziest thing was that they wanted vestibules into the bottling room and that it had to be a clean room, meaning no box storage or supplies, just bottling. Now, I would never point out one of the small guys, but I showed them Buffalo Traces' bottling room camera. The room has ceiling fans, awards, etc. Nobody wears hair nets or anything like that. But they wanted ours to be that way.

5. They (WV) tried to get me to pay a $500 fee for a food processing facility. I told them I'd be happy to do that if they removed my $1500 annual fee for a distillery.

We are clean here and take great pride in what we do. I felt a little bit like they were forced to do this and really didn't know what they were looking at/for. They haven't been back.

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Hoses on the floor are not only a trip hazard but assuming they are not in use, the FDA would be concerned with them not draining well, holding water, bacterial growth issue. Duct tape isn't a FDA approved material for food transfer, all materials for hoses and conveyors should all be FDA approved, they were assuming the duct tape might come in contact with food product.

I'm not an expert by any means, but I do believe breweries, wineries and distilleries are exempt from most of the FSMA requirements, like the bottling clean room. The list of things they can make you do gets shorter if you get rid of FSMA. HAACP as an example is not required.

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We're in Toronto and required to register with the FDA and get a Foreign Facility Registration #, and agree to FDA inspections here in Canada. We also have to give the FDA advance notice of every shipment into the U.S., or CBP won't release the cargo. FDA can and does take samples from pallets on occasion.

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I was given a tip once about having a business inspected.

Purposely have one minor but obvious fault that the inspector can find, eg a fluoro light cover missing, or a piece of gaffa tape in the wrong place.

They might then be satisfied that they have done their job and not look too much harder.

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Hoses on the floor could be a trip hazard but why would she ask for the duct tape be removed?

LOL... we just have a saying at our shop (family owned and operated) If you can trip over it, burn yourself, or gouge yourself, you will... so watch out.

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I was given a tip once about having a business inspected.

Purposely have one minor but obvious fault that the inspector can find, eg a fluoro light cover missing, or a piece of gaffa tape in the wrong place.

They might then be satisfied that they have done their job and not look too much harder.

bingo...

just passed our annual fire inspection today too.. phew... that makes FDA, Hazmat, AND fire guys all in the last 2 months... Talk about sleepless nights. Even though we passed them all with flying colors, its still pretty nerve racking

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  • 3 weeks later...

We also recently had an unannounced FDA inspection. Worse yet it was a supervisor and a trainee, so the trainee was going through a very detailed checklist. List of required actions were not terribly long and were reasonable for the most part. They were particularly interested in our SOPs. We've also had a fire marshall inspection. If these things come in 3s, maybe the TTB will be next. They're less than a mile away.

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We just came out the other end of a TTB audit, what a headache for only $300 and a few misplaced cells on a report. That being said, the inspector was really nice and when we mentioned that our friend's distillery had been inspected by the FDA , she seemed very concerned and wrote a note in her journal. I have a sneaking suspicion that the FDA is coming our way next, it would be helpful to know what they'll be looking for so we can prepare for it.

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