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Inspection References
Investigations Operations Manual 2004
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Chapter 2 - Organization

SUBCHAPTER 200 - ORGANIZATION OVERVIEW
201 - FDA PRINCIPLES
SUBCHAPTER 210 - OFFICE OF THE COMMISSIONER
210 - IMMEDIATE OFFICE (OC)(HF-1) Pg 34
211 - OFFICE OF THE SENIOR ASSOCIATE COMMISSIONER (HF- 2)
212 - OFFICE OF POLICY, PLANNING, AND LEGISLATION (HF-22)
213 - OFFICE OF MANAGEMENT (HF-20)
214 - OFFICE OF INTERNATIONAL AND CONSTITUENT RELATIONS (HF-24)
SUBCHAPTER 220 - CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
220 - OFFICE OF THE CENTER DIRECTOR
     220.01 - Office of Biostatistics and Epidemiology (OBE) (HFM-210)
221 - OFFICE OF COMMUNICATION, TRAINING, AND MANUFACTURERS ASSISTANCE (OCTMA) (HFM-40)
222 - OFFICE OF MANAGEMENT (OM) (HFM-100)
     222.01 - Office of Information Technology Management (OITM) (HFM-160)
223 - OFFICE OF BLOOD RESEARCH AND REVIEW (OBRR) (HFM-300)
224 - OFFICE OF VACCINES RESEARCH AND REVIEW (OVRR) (HFM-400)
225 - OFFICE OF CELLULAR TISSUE AND GENE THERAPIES
226 - OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY (HFM-600)
SUBCHAPTER 230 - CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
230 - OFFICE OF THE CENTER DIRECTOR (HFD-1)
231 - OFFICE OF MANAGEMENT (HFD-10) RUSSELL ABBOTT, DIRECTOR
232 - OFFICE OF INFORMATION TECHNOLOGY (HFD-070)
233 - OFFICE OF TRAINING AND COMMUNICATIONS (HFD-200)
234 - OFFICE OF COMPLIANCE (HFD-300),
235 - OFFICE OF PHARMACEUTICAL SCIENCE, (HFD-3) DEPUTY CENTER
     235.01 - Office of New Drug Chemistry (HFD-800)
     235.02 - Office of Generic Drugs (HFD-600),
     235.03 - Office of Testing and Research (HFD-900)
     235.04 - Office of Clinical Pharmacology & Biopharmaceutics (HFD-850)
236 - OFFICE OF REVIEW MANAGEMENT (HFD-20)
     236.01 - Office of Drug Evaluation I (HFD-101)
     236.02 - Office of Drug Evaluation II (HFD-102)
     236.03 - Office of Drug Evaluation III (HFD-103)
     236.04 - Office of Drug Evaluation IV (HFD-104)
     236.05 - Office of Drug Evaluation V (HFD-105)
     236.06 - Office of Biostatistics (HFD-700)
     236.07 - Office of Post Marketing Drug Risk
SUBCHAPTER 240 - CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)
240 - OFFICE OF THE CENTER DIRECTOR
241 - OFFICE OF SYSTEMS AND MANAGEMENT (HFZ-2) RUTH CLEMENTS, DIRECTOR
242 - OFFICE OF SCIENCE AND TECHNOLOGY (HFZ-100) LARRY KESSLER, Sc.D., DIRECTOR
243 - OFFICE OF HEALTH AND INDUSTRY PROGRAMS, (HFZ-200) LIREKA P. JOSEPH, Ph.D., DIRECTOR
244 - OFFICE OF COMPLIANCE (HFZ-300) TIM ULATOWSKI, DIRECTOR
245 - OFFICE OF DEVICE EVALUATION (HFZ-400), DANIEL SCHULTZ, M.D., Ph.D. , DIRECTOR
246 - OFFICE OF SURVEILLANCE AND BIOMETRICS (HFZ-500) SUSAN N. GARDNER, Ph.D., DIRECTOR
247 - OFFICE OF IN VITRO DIAGNOSTICS (HFZ-440) STEVE GUTMAN, M.D., DIRECTOR
SUBCHAPTER 250 - CENTER FOR VETERINARY MEDICINE (CVM)
250 - OFFICE OF THE CENTER DIRECTOR (HFV-1)
251 - OFFICE OF MANAGEMENT AND COMMUNICATION (HFV-10)
252 - OFFICE OF NEW ANIMAL DRUG EVALUATION (HFV-100)
253 - OFFICE OF SURVEILLANCE AND COMPLIANCE (HFV-200)
254 - OFFICE OF RESEARCH (HFV-500)
SUBCHAPTER 260 - CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
260 - OFFICE OF THE CENTER DIRECTOR
     260.01 - Food Safety Staff (HFS-32) Vacant, Director
     260.02 - Office of Regulation and Policy (HFS-4), L. Robert Lake, Director
     260.021 - Office of Constituent Operations
     260.03 - Office of Management Systems (HFS-650), Juanita Wills, Director
     260.04 - Office of Science (HFS-6) Robert L. Buchanan
261 - OFFICE OF THE DEPUTY DIRECTOR, JANICE F. OLIVER
     261.01 - Associate Director of Operations, Arnold P. Borsetti, Ph.D.
     261.02 - EEO Office, Joan J. Jappa, Ph.D.
     261.03 - Executive Operations Staff, Catherine J. Bailey, Director
     261.04 - Office of Cosmetics and Colors (HFS-100), Linda Katz, Ph.D., Director
     261.05 - Office of Nutritional Products, Labeling and Dietary Supplements (HFS-800), Christine J. Taylor, Ph.D., Director
     261.06 - Office of Food Additive Safety (HFS-200), Alan M. Rulis, Ph.D., Director
     261.07 - Office of Plant and Dairy Food and Beverages (HFS-300) Terry C. Troxell, Ph.D., Director
     261.08 - Office of Seafoods (HFS-400), Philip Spiller, Director
     261.09 - Office of Applied Research and Safety Assessment (HFS-025), Thomas A. Cebula, Director
     261.10 - Office of Compliance (HFS-600), Joseph Baca, Director
     261.11 - Office of Scientific Analysis and Support (HFS-700) Kenneth J. Falci, Ph.D., Director
SUBCHAPTER 270 - OFFICE OF REGULATORY AFFAIRS
270 - ASSOCIATE COMMISSIONER FOR REGULATORY AFFAIRS (HFC-1)
271 - ORA HEADQUARTERS ORGANIZATION
     271.01 - Office of Resource Management (ORM) (HFC-10), James M. Strachan, Director
     271.02 - Office of Regional Operations (ORO) (HFC-100) Deborah D. Ralston, Director
     271.03 - Office of Enforcement (OE) - HFC-200 David K. Elder, Director
     271.04 - Office of Criminal Investigations (OCI) (HFC-300) Terrell L. Vermillion, Director
272 - ORA FIELD ORGANIZATION

 

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