The opinion of the court was delivered by: Hon. Virginia A. Phillips
CONSENT DECREE OF PERMANENT INJUNCTION
Plaintiff, the United States of America, by its undersigned attorneys, having filed a Complaint for Permanent Injunction against Defendants Gorzeman Dairy L.P., a limited partnership, and Glenn A. Gorzeman, an individual (collectively, "Defendants"), and Defendants, solely for the purpose of settlement of this case, and without admitting or denying the allegations of the Complaint, having appeared and consented to the entry of this Consent Decree of Permanent Injunction ("Decree"), without contest and before any testimony has been taken, and the United States of America having consented to this Decree;
IT IS HEREBY ORDERED, ADJUDGED, AND DECREED that:
I. This Court has jurisdiction over the subject matter and over all parties to this action.
II. The Complaint for Permanent Injunction states a cause of action against Defendants under the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.C. §§ 301 et seq.
III. The Complaint alleges that Defendants violate 21 U.S.C. § 331(a) by introducing, delivering, and causing to be introduced or delivered into interstate commerce articles of food within the meaning of 21 U.S.C. § 321(f) that are adulterated within the meaning of 21 U.S.C. §§ 342(a)(2)(C)(ii) and 342(a)(4).
IV. Defendants and each and all of their agents, representatives, employees, attorneys, successors, assigns, and any and all persons in active concert or participation with any of them who have received notice of this Decree, are hereby permanently restrained and enjoined, under the provisions of 21 U.S.C. § 332(a) and the inherent equity authority of this Court, from directly or indirectly introducing, delivering, or causing to be introduced or delivered into interstate commerce, any article of food within the meaning of 21 U.S.C. § 321(f), and administering to animals any new animal drug, within the meaning of 21 U.S.C. § 321(v), while such drug is held for sale after shipment in intestate commerce, unless and until:
A. Defendants have established and implemented a system that ensures that each of the animals that they acquire, purchase, hold, transport, sell, or consign is individually and permanently identified by tag number;
B. Defendants have established and implemented a written record-keeping system that prevents them from selling, consigning, or distributing any animals whose edible tissue contain new animal drugs in amounts above the levels permitted by law. This system shall include, but not necessarily be limited to, keeping written records on every animal to which Defendants administer drugs. These records shall include, at a minimum: (1) the identity of each animal that Defendants medicate; (2) the date of each administration of each medication to each animal; (3) the identity of each drug administered; (4) the dosage of each drug used; (5) the route of administration of each drug used; (6) the lawful written order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship for each drug used, if applicable; (7) the name of the person administering each drug;
(8) the proper withdrawal period for each drug administered; (9) the date such withdrawal period will terminate for each drug administered; (10) the date each medicated animal is shipped for slaughter or leaves Defendants' control; and (11) the name and address of the purchaser, receiver, or consignee, of each medicated animal that is shipped for slaughter or leaves Defendants' control;
C. Defendants have established and implemented a system that ensures that their use of new animal drugs conforms to the use approved by the United States Food and Drug Administration ("FDA") as set forth in the drugs' approved labeling or to the lawful written orders of a licensed veterinarian, so long as those orders do not result in illegal residues. This system shall include, but not necessarily be limited to, measures to ensure that the following will not occur: (1) administration of drugs in excess of the approved dosage, unless such administration is in accordance with the lawful written orders of a licensed veterinarian within the context of a valid veterinarian- client-patient relationship and is in compliance with 21 C.F.R. § 530; (2) sale or delivery for slaughter of medicated animals before the expiration of the relevant withdrawal period; and (3) use in Defendants' animals of drugs not approved for use in that species or not approved for the disease or other condition for which the animal is being treated, unless such use is in accordance with the lawful written orders of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship and is in compliance with 21 C.F.R. § 530;
D. Defendants have established and implemented a drug inventory and accountability system that prevents them from selling, consigning, or delivering any animals with illegal new animal drug residues. This system shall include a written record for each drug that Defendants purchase or receive for use in medicating any of their animals, which record shall include, but not necessarily be limited to: (1) the name of the drug;
(2) the date of purchase or receipt of the drug; (3) the quantity, strength, and form of the ...