Just to keep the targeted company in a state of constant fear (which is why I have labeled the FDA a terrorist organization), the FDA forces it to agree to surprise inspections where it must pay FDA "compliance officers" to rummage through their product shelves and paperwork, looking for evidence of non-compliance:
Duly authorized representatives of FDA shall be permitted, without prior notice and as and when FDA deems necessary, to make [surprise] inspections of Defendants' facilities and, without prior notice, take any other measures necessary to monitor and ensure continuing compliance with the terms of this Decree. During such inspections, FDA representatives shall be permitted prompt access to buildings, equipment, in-process and finished materials, containers, labeling and other materials therein; to take photographs and make video recordings; to take samples of Defendants' finished and unfinished materials and products, containers, labels, labeling, and other promotional materials; and to examine and copy all records relating to the receipt, manufacture, processing, packing, labeling, promoting, holding, and distribution of any and all Defendants' products in order to ensure continuing compliance with the terms of this Decree. The inspections shall be permitted upon presentation of a copy of this Decree and appropriate credentials. The inspection authority granted by this Decree is separate from, and in addition to, the authority to conduct inspections under the Act, 21 U.S.C. §374.
And just to make sure the company is further driven into bankruptcy, the FDA requires them to PAY for all these surprise "compliance" investigations! As stated in the Consent Decree:
Defendants shall reimburse FDA for the costs of all FDA inspections, investigations, supervision, reviews, examinations, and analyses specified in this Decree or that FDA deems necessary to evaluate Defendants' compliance with this Decree. The costs of such inspections shall be borne by Defendants at the prevailing rates in effect at the time the costs are incurred. As of the date that this Decree is signed by the parties, these rates are: $78.09 per hour and fraction thereof per representative for inspection work; $93.61 per hour or fraction thereof per representative for analytical or review work; $0.485 per mile for travel expenses by automobile; government rate or the equivalent for travel by air or other means; and the published government per diem rate or the equivalent for the areas in which the inspections are performed per-day, per-representative for subsistence expenses, where necessary. In the event that the standard rates applicable to FDA supervision of court-ordered compliance are modified, these rates shall be increased or decreased without further order of the Court."
Are you getting the picture here? The FDA can simply show up on a "surprise" inspection, bring ten FDA agents, bill the company for thousands of hours, and bankrupt the company while padding its own pockets.
Doesn't this sound a lot like the King's Consent Decree against the American colonies? The FDA's agreement reads amazingly like a document a King might force his subjects to sign as he's taking over their land and gold, imprisoning them in his kingdom.
But it gets better: The FDA also requires the Defendants to reveal all sorts of details about their business operations:
"Within ten (10) calendar days of entry of this Decree, Defendants shall provide FDA a list of all domain names and IP addresses they use to market or describe any product, regardless of whether such sites mention specific products Defendants sell.
Defendants shall notify the District Director, FDA Detroit District Office, in writing at least fifteen (15) calendar days before any change in ownership, character, or name of its business.
If Defendants fail to comply with any of the provisions of this Decree, including any time frame imposed by this Decree, then, on motion of the United States in this proceeding, Defendants Brownwood Acres and/or Cherry Capital shall pay to the United States of America the sum of one thousand dollars ($1,000) in liquidated damages per violation per day so long as such violation continues.
Should the United States bring, and prevail in, a contempt action to enforce the terms of this Decree, Defendants shall, in addition to other remedies, reimburse the United States for its attorneys* fees, investigational expenses, expert witness fees, travel expenses incurred by attorneys and witnesses, and administrative court costs relating to such contempt proceedings.
And finally, just to make sure everybody knows who's in charge, here's what the agreement says about final judgment:
All decisions specified in this Decree shall be vested in the discretion of FDA and shall be final.
In other words, the FDA is the King. It is above the law. It answers to no one but itself.
Welcome to the United States of Tyranny, FDA style.
The full text of the FDA's agreement, including the names of the top FDA criminals who signed it, is included at the end of this article.
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