IN THE UNITED STATES DISTRICT COURTFOR THE DISTRICT OF COLUMBIAUNITED STATES OF AMERICA, )))Plaintiff, ))v. ) Civil Action No. 10-cv-1327 (RMC))REGENERATIVE SCIENCES, LLC,

et al.

, ))Defendants. )ORDER OF

PERMANENT INJUNCTION

 The Court having considere

d Plaintiff’s motion for summary

judgment and supportingdocuments and any opposition thereto; having found that the cultured cell product is a drugwithin the meaning of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(g) (

“

FDCA

”

)and a biological product within the meaning of 42 U.S.C. § 262; having found that RegenerativeSciences, LLC, a corporation, and Christopher J. Centeno, M.D., John R. Schultz, M.D., andMichelle R. Cheever, individuals (collectively

, “D

efenda

nts”)

are causing the adulteration andmisbranding of the cultured cell product within the meaning of 21 U.S.C. §§ 351(a)(2)(B),352(f)(1) and 353(b)(4), while it is held for sale after shipment of one or more of its componentsin interstate commerce; and having found that the Defendants, unless restrained by order of thisCourt, will continue to violate the FDCA,IT IS HEREBY ORDERED, ADJUDGED, AND DECREED that:1.

Plaintiff’s motion for summary

judgment is granted.2. This Court has jurisdiction over the subject matter and all parties to this action.

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23. The Complaint states a cause of action against the Defendants under the FDCA.4. For purposes of this Order, the ter

m “dru

g

” shall r 

efer to any human cell, tissue, orcellular or tissue-based product (

“HCT/P”) as de

fined in 21 C.F.R. § 1271.3(d) that does notmeet all of the criteria in 21 C.F.R. § 1271.10 or the criteria for an exception in 21 C.F.R.§ 1271.15.5. Defendants, and all of their directors, officers, agents, employees, successors,representatives, assigns, and attorneys, and any and all persons in active concert or participationwith any of them, who have received actual notice of this Order by personal service or otherwise,are hereby permanently enjoined under 21 U.S.C. § 332(a) from directly or indirectly doing orcausing to be done any act that:A. Violates 21 U.S.C. § 331(k) by causing any drug within the meaning of 21 U.S.C. § 321(g) to become adulterated within the meaning of 21 U.S.C. § 351(a)(2)(B) or tobecome misbranded within the meaning of 21 U.S.C. § 352(f)(1) or § 353(b)(4), while sucharticle is held for sale after shipment of one or more of its components in interstate commerce.B. Violates 21 U.S.C. § 331 (a) by introducing or causing to be introduced, ordelivering or causing to be delivered for introduction, into interstate commerce any drug that isadulterated within the meaning of 21 U.S.C. § 351(a)(2)(B) or misbranded within the meaning of 21 U.S.C. § 352(f)(1) or § 353(b)(4).6. Defendants and each and all of their directors, officers, agents, employees,representatives, successors, assigns, attorneys, and any and all persons in active concert orparticipation with any of them, who have received actual notice of this Order by personal service

Case 1:10-cv-01327-RMC Document 48 Filed 07/23/12 Page 2 of 12

 

 

3or otherwise, are permanently restrained and enjoined under 21 U.S.C. § 332(a) from directly orindirectly manufacturing, processing, packing, repacking, labeling, and distributing the culturedcell product or any other drug, unless and until:A. Def 

endants’ m

ethods, facilities, and controls used to manufacture, process,pack, repack, label, hold, and distribute such products are established, operated, and administeredin conformity with current good manufacturing practice, 21 U.S.C. § 351(a)(2)(B) and 21 C.F.R.Parts 210-211, 600-680, and 1271 (hereafter,

“CGMP”);

 B. Defendants retain, at Def 

endants’

expense, an independent person orpersons (the

“expert”

), without personal or financial ties (other than the consulting agreementbetween the parties) to Defendants or their immediate families, who by reason of background,experience, education, and training, is qualified to inspect Defenda

nts’ fa

cilities to determinewhether their methods, facilities, and controls are operated and administered in conformity withCGMP and to evaluate the labeling of Defenda

nts’

cultured cell product and any other drugsmanufactured, processed, packed, labeled, held, and distributed by Defendants to determinewhether they are in compliance with 21 U.S.C. §§ 352(f) and 353(b)(4). Defendants shall notifyFDA in writing of the identity of the expert within ten (10) days of retaining such expert;C. The expert shall perform a comprehensive inspection of Defenda

nts’

facility at 6850 West 116th Avenue, Unit D, Broomfield, Colorado and any other location atwhich Defendants manufacture, process, pack, repack, label, hold, or distribute the cultured cellproduct or any other drug, and the methods and controls used to manufacture, process, package,repackage, label, hold, and distribute such products to determine whether such facilities,

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