22. All decisions specified in this Decree shall be vested in the discretion of FDA and shall be final. If contested, FDA's decisions under this Decree shall be reviewed by the Court under the arbitrary and capricious standard set forth in 5 U.S.C. § 706(2)(A). Review shall be based exclusively on the written record before FDA at the time the decision was made. No discovery shall be taken by either party.
23. If, in FDA's judgment, Defendants maintain a continuous state of compliance with this Decree and the Act for a period of three (3) years after the date of entry of this Decree, and FDA has not notified Defendants that there has been a significant violation of this Decree or the Act during such time, the government will not oppose Defendants' petition to the Court to dissolve the Decree.
24. This Court retains jurisdiction of this action for the purpose of enforcing or modifying this Decree and for the purpose of granting such additional relief as may be necessary or appropriate.
IT IS SO ORDERED:
Dated this_day of_, 2008.
UNITED STATES DISTRICT JUDGE
FOR PLAINTIFF
CHARLES R. GROSS
United States Attorney Western District of Michigan
W. FRANCESCA FERGUSON
Assistant U.S. Attorney
ALAN J. PHELPS
Trial Attorney
Office of Consumer Litigation Department of Justice Civil Division P.O. Box 386 Washington, D.C. 20044
OF COUNSEL:
JAMES C. STANSEL
Acting General Counsel
GERALD F. MASOUDI
Chief Counsel
Food and Drug Division
23. If, in FDA's judgment, Defendants maintain a continuous state of compliance with this Decree and the Act for a period of three (3) years after the date of entry of this Decree, and FDA has not notified Defendants that there has been a significant violation of this Decree or the Act during such time, the government will not oppose Defendants' petition to the Court to dissolve the Decree.
24. This Court retains jurisdiction of this action for the purpose of enforcing or modifying this Decree and for the purpose of granting such additional relief as may be necessary or appropriate.
IT IS SO ORDERED:
UNITED STATES DISTRICT JUDGE
FOR PLAINTIFF
CHARLES R. GROSS
United States Attorney Western District of Michigan
W. FRANCESCA FERGUSON
Assistant U.S. Attorney
ALAN J. PHELPS
Trial Attorney
Office of Consumer Litigation Department of Justice Civil Division P.O. Box 386 Washington, D.C. 20044
OF COUNSEL:
JAMES C. STANSEL
Acting General Counsel
GERALD F. MASOUDI
Chief Counsel
Food and Drug Division
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