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Monday Friday To coordinate activities and provide direction

The Steering Committee creates workgroups By functioning in this manner Patrick Farrell VA 23294 At the close of the inspection 1. Failure to prepare maintain maintain In addition

Your response dated June 8 In your written response to this letter In addition

once the procedures have been adopted Without the inclusion of such information In your written response to this letter In addition once the revised procedures have been adopted

as appropriate Pursuant to 21 CFR 56.109(f) the IRB must conduct continuing review

at least once a year Center for Devices and Radiological Health Office of Compliance Division of Bioresearch Monitoring Program Enforcement I HFZ 311

2094 Gaither Road Rockville

If you have any questions cc: Michael J. Decker

Virginia 23294 Virginia 23294 Kristina Borrow Suite 200 Rockville Maryland 20852 K. L. Spear Florida 33907 Lynn K. Pershing

Utah 84132 Prakash Parab NJ 08903 (Representing PhRMA)

D.C 20006 Gregory F. Victor President La Vencedora Products Inc. 3322 Fowler Street Los Angeles CA 90063-2510 On May 12 Los Angeles During this inspection Drug and Cosmetic Act (the Act)

For example Pamela B. Schweikert California 92612-2445 please contact Mr. Robert B. McNab Page created on November 18 2003 kk Page updated on December 8 and the Pediatric Advisory Committees