CHRISTOPHER J. CHRISTIE
United States Attorney
MICHAEL A. CHAGARES
Assistant U.S. Attorney
Chief, Civil Division
970 Broad Street, Suite 700
Newark, New Jersey 07101
(973)645-2839
MC-5483
GERALD C. KELL
Senior Trial Counsel
Office of Consumer Litigation
Civil Division
U.S. Department of Justice
P.O. Box 386
Washington, D.C. 20044
(202)514-1586
GK-1647
Attorneys for Plaintiff
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
___________________________________
UNITED STATES OF AMERICA, )
)
Plaintiff, )
)
v. ) No.
)
SCHERING-PLOUGH CORPORATION, and )
SCHERING-PLOUGH PRODUCTS, LLC, )
corporations, and ) COMPLAINT FOR INJUNCTION
)
RICHARD J. KOGAN, and )
STEVEN C. CHELLEVOLD, )
individuals, )
)
Defendants. )
___________________________________)
The United States of America, Plaintiff, by Robert J.
1
SNIPPETS:
Assistant U.S. Attorney
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
This statutory injunction proceeding is brought under
the Federal Food, Drug, and Cosmetic Act, 21
to enjoin defendants Schering-Plough
Corporation and Schering-Plough Products, LLC, a subsidiary of
Schering-Plough Corporation, and Steven C. Chellevold, Senior-Vice President, Worldwide
Products, LLC, individuals (hereinafter, collectively,
or the facilities or controls used
for, its manufacture, processing, packing, or holding do not
that the drug meets the requirements of the FDC Act as to
directly or indirectly manufacturing, processing, or packing
articles of human or veterinary drug,
components in interstate commerce, or the doing of any other
the meaning of 21 U.S.C. § 351.
This Court has jurisdiction over the subject matter
at facilities located worldwide, including facilities located
Puerto Rico 00674 and State Road 183 PRIDCO Industrial
DEFENDANTS' HISTORY OF VIOLATIONS
FDA conducted four inspections of Defendants' New Jersey
FDA's inspections of Defendants' New Jersey
also revealed significant CGMP violations, including, but not
331, by directly or indirectly causing articles of drug, as
conform to and are not operated or administered in conformity
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