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United States v. Vivaceuticals, Inc.

United States District Court, C.D. California

February 8, 2017

UNITED STATES OF AMERICA, Plaintiff,
v.
VIVACEUTICALS, INC., et al., Defendants.

          CONSENT DECREE

          HON. JOSEPHINE L. STATON UNITED STATES DISTRICT JUDGE

         CONSENT DECREE OF PERMANENT INJUNCTION

         Plaintiff, the United States of America, by its undersigned counsel, having filed a Complaint for Permanent Injunction against VivaCeuticals, Inc., doing business as Regeneca Worldwide, a corporation, and Matthew A. Nicosia, an individual (collectively, “Defendants”), and Defendants having appeared and consented to entry of this Decree without contest, without admitting or denying the allegations in the Complaint, 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 as follows:

         1. This Court has jurisdiction over the subject matter and all parties to this action.

         2. The Complaint states a cause of action against Defendants under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. (the “Act”).

         3. The Complaint alleges that Defendants violate 21 U.S.C. § 331(a) by introducing or delivering for introduction, or causing to be introduced or delivered for introduction, into interstate commerce articles of food (dietary supplements), as defined by 21 U.S.C. § 321(ff), that are:

A. Adulterated within the meaning of 21 U.S.C. § 342(g)(1) in that they have been prepared, packed, or held in violation of current good manufacturing practice regulations for dietary supplements (“Dietary Supplement CGMP”), set forth in 21 C.F.R. Part 111;
B. Adulterated within the meaning of 21 U.S.C. § 342(a)(2)(C)(i) in that they contain a food additive that is unsafe within the meaning of 21 U.S.C. § 348(a); and/or
C. Misbranded within the meaning of 21 U.S.C. § 343(a)(1) because their labeling is false or misleading.

         4. The Complaint alleges that Defendants violate 21 U.S.C. § 331(k) by causing articles of food (dietary supplements) that are held for sale after shipment of one or more components in interstate commerce to become:

A. Adulterated within the meaning of 21 U.S.C. § 342(g)(1);
B. Adulterated within the meaning of 21 U.S.C. § 342(a)(2)(C)(i); and/or
C. Misbranded within the meaning of 21 U.S.C. § 343(a)(1).

         5. The Complaint alleges that Defendants violate 21 U.S.C. § 331(d) by introducing or delivering for introduction, or causing to be introduced or delivered for introduction, into interstate commerce a new drug, as defined by 21 U.S.C. § 321(p), that is neither approved pursuant to 21 U.S.C. § 355(a) nor exempt from approval pursuant to 21 U.S.C. § 355(i).

         6. The Complaint alleges that Defendants violate 21 U.S.C. § 331(k) by causing an article of drug that is held for sale after shipment of one or more components in interstate commerce to become misbranded within the meaning of 21 U.S.C. § 352(f)(1) because its labeling fails to bear adequate directions for use.

         7. Upon entry of this Decree, Defendants and each and all of their directors, officers, agents, representatives, employees, attorneys, successors and assigns, and any and all persons or entities in active concert or participation with any of them (including parent companies, holding companies, subsidiaries, affiliates, franchisees, “doing business as” entities, “consultants, ” “independent contractors, ” “independent business owners, ” and any other persons engaged in any part of the manufacture, preparing, packing, labeling, holding, and/or distribution of Defendants' products) (hereinafter, collectively referred to as “Associated Persons”), who have received actual notice of this Decree by personal service or otherwise, are permanently restrained and enjoined under 21 U.S.C. § 332(a), and the inherent equitable authority of this Court, from directly or indirectly receiving, manufacturing, preparing, packing, repacking, labeling, holding, or distributing any articles of food (including but not limited to dietary supplements and their components) and/or articles of drug, at or from 2 Park Plaza, Suite 1200, Irvine, California 92614, or 16 Technology Drive, Suite 124, Irvine, California 92618, or at or from any other location(s) at which Defendants now or in the future directly or indirectly receive, manufacture, prepare, pack, repack, label, hold, or distribute any articles of food (including but not limited to dietary supplements and their components) and/or articles of drug (referred to as “Defendants' Facility” or “the Facility”) unless and until:

         A. Defendants retain, at Defendants' expense, an independent person (the “CGMP Expert”) who is without any personal or financial ties (other than a retention agreement) to Defendants and/or their families, and who, by reason of background, training, education, or experience, is qualified to inspect the Facility to determine whether Defendants' methods, processes, and controls are: (1) operated and administered in conformity with Dietary Supplement CGMP (21 C.F.R. Part 111); (2) adequate to ensure that none of the dietary supplements that Defendants receive, manufacture, prepare, pack, repack, label, hold, or distribute contain a food additive that is unsafe within the meaning of 21 U.S.C. § 348(a); and (3) adequate to ensure that none of the products that Defendants receive, manufacture, prepare, pack, repack, label, hold, or distribute, and that Defendants market as, or intend to market as, dietary supplements, contain an article “approved as a new drug” or “authorized for investigation as a new drug” within the meaning of 21 U.S.C. § 321(ff)(3)(B);

         B. Defendants notify FDA in writing of the identity and qualifications of the CGMP Expert within three (3) business days of retaining such expert, and the CGMP Expert:

         1. Performs a comprehensive inspection of the Facility and the methods, processes, and controls used to receive, manufacture, prepare, pack, repack, label, hold, and distribute dietary supplements; 2. Certifies in writing to FDA that:

(a) He or she has inspected the Facility, methods, processes, and controls;
(b) All deviations from Dietary Supplement CGMP, the requirements in 21 U.S.C. § 348(a), and the provisions in 21 U.S.C. § 321(ff)(3)(B), that have been brought to Defendants' attention by FDA, the CGMP Expert, and any other source since April 2011, have been corrected; and
(c) Defendants' Facility and the methods, processes, and controls used to receive, manufacture, prepare, pack, repack, label, hold, or distribute dietary supplements are, in the CGMP Expert's opinion, in compliance with this Decree, the Act, and its implementing regulations; and 3. Prepares a detailed report, which shall be submitted to FDA as part of the certification described in paragraph 7(B)(2), of the CGMP Expert's inspection that shall include, but not be limited to, a determination that:
(a) Defendants have implemented corrections to their facilities, methods, processes, and controls that are adequate to ensure that they comply with Dietary Supplement CGMP and at a minimum:
(i) Establish an identity specification for each component as well as component specifications to ensure that specifications for the purity, strength, and composition of the finished batch of dietary supplements manufactured using the component are met, as required by 21 C.F.R. § 111.70(b);
(ii) Establish product specifications for the identity, purity, strength, and composition of the finished batch of dietary supplements, and for limits on the types of contamination that may adulterate, or may lead to adulteration of, the finished batch of the dietary supplements to ensure its quality, as required by 21 C.F.R. § 111.70(e);
(iii) Conduct at least one appropriate test or examination to verify the identity of every component that is a dietary ingredient before using such component, as required by 21 C.F.R. § 111.75(a)(1)(i);
(iv) Determine whether component specifications that must be established in accordance with 21 C.F.R. § 111.70(b) are met before using such component, as required by 21 C.F.R. § 111.75(a)(2);
(v) Prepare and follow a complete written master manufacturing record for each unique formulation of dietary supplements, and for each batch size, to ensure uniformity in the finished product from batch to batch, as required by 21 C.F.R. § 111.205;
(vi) Prepare a batch production record every time a batch of dietary supplements is manufactured, as required by 21 C.F.R. § 111.255;
(vii) Establish and follow written procedures for the responsibilities of the quality control operations set forth in 21 C.F.R. ยง 111.105, as ...

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