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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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1-9 - ENFORCEMENT POLICY DIRECTORY

1-9 - ENFORCEMENT POLICY DIRECTORY
     1-9-1 - Office of Regulatory Affairs - Headquarters
     1-9-2 - Office of Regulatory Affairs - Field
     1-9-3 - FDA Centers

 1-9 - ENFORCEMENT POLICY DIRECTORY

The most current version of this directory is available on FDA's Intranet website.

 1-9-1 - Office of Regulatory Affairs - Headquarters

Associate Commissioner for Regulatory Affairs (ACRA)
  1. ACRA301-796-8800
    1. Deputy for Field Operations301-796-8800
    2. Deputy for Compliance Policy301-796-8810
Office of Enforcement (OE)
  1. Director, OE301-796-8314
  2. Compliance Policy Council Internet Regulatory Policy and Enforcement
    1. Director of Compliance, OE301-796-8314
    2. Director, Division of Compliance Management and Operations301-796-8200
    3. Director, Division of Compliance Policy301-796-3820
    4. Director, Division of Compliance Information and Quality Assurance301-796-5300
  3. Division of Compliance Management and Operations301-796-8200
    • Case Review and Management
    • Civil Money Penalties (Compliance)
    • Inspection Warrants
    • Recalls
    • Team Biologics (Compliance)
    • Warning Letter Database
  4. Division of Compliance Policy301-796-3820
    • Bioresearch Misconduct and Monitoring
    • Good Guidance Practices (GGPs)
    • Good Laboratory Practices (GLPs)/Non-Clinical
    • Information Disclosure (including FOI)
    • Policy (Biologics, Civil Money Penalties, Cosmetics, Drugs, Foods, Medical Devices, Veterinary Medicine, and Radiation Emitting Electronic Products)
    • Publications (Compliance Policy Guides Manual, Enforcement Notes, Information Disclosure Manual, Regulatory Procedures Manual)
    • Testimony
  5. Division of Compliance Information and Quality Assurance301-796-5300
    • Electronic Regulatory Information Assurance
    • FACTS Firm Profiles (COMSTAT)
    • Government-Wide Quality Assurance Program (GWQAP)
    • Compliance Management System
    • Turbo EIR
    • Health Communications
Office of Regional Operations (ORO)
  1. Director, ORO301-796-5753
  2. Director, Division of Domestic Field Investigations301-796-5403
  3. Director, Division of Foreign Field Investigations301-796-5521
  4. Director, Division of Field Science301-796-5955
  5. Director, Division of Federal/State Relations301-796-5810
  6. Director, Division of Import Operations & Policy301-796-0356
    1. Director, Operations & Policy Branch301-796-6677
    2. Director, Systems Branch301-796-8997
      (As of October 18, 2002 Emergency Operations has been
      organized structurally as Office of Emergency Operations,
      Office of Crisis Management, Office of the Commissioner)
Office of Resource Management (ORM)
  1. Director, ORM301-796-4300
  2. Deputy Director, ORM301-796-4300
Office of Criminal Investigations (OCI)
  1. Acting Director, OCI240-276-9441
  2.  

 1-9-2 - Office of Regulatory Affairs - Field

Northeast Region
  1. Regional Food and Drug Director, HFR-NE1781-587-7533
  2. FAX781-587-7556
  3. Deputy Regional Food and Drug Director, HFR-NE2718-662-5610
  4. FAX718-662-5434
  1. New York District Office718-340-7000
    1. District Director, HFR-100718-662-5447
    2. FAX 781-662-5665
      • Director Compliance Branch, HFR NE340716-551-4461 x3116
      • FAX716-551-4499
  2. New England District Office781-587-7500
    1. District Director, HFR-NE200781-587-7490
    2. FAX781-587-7556
    3. Director Compliance Branch, HFR-NE240 781-587-7488
    4. FAX 781-587-7556
  3. Winchester Engineering & Analytical Center 781-756-9700
    1. Director, HFR-NE400781-756-9701
    2. FAX781-756-9757
  4. Northeast Regional Laboratory
    1. Director, HFR-NE500718-662-5450
    2. FAX718-662-5439
Central Region
  1. Regional Food and Drug Director, CHI-FO, HFR-CE1312-596-6501
  2. FAX312-886-1682
  3. Deputy Regional Food and Drug Director, PHI-FO HFR-CE2 215-717-3701 FAX215-597-5798
  1. Baltimore District Office
    1. District Director, HFR-CE200410-779-5424
      • Director Compliance Branch, HFR-CE240410-779-5417 FAX 410-779-5707
  2. Chicago District Office
    1. District Director, HFR-CE600 312-596-4200
      • Director Compliance Branch, HFR-CE640
      • FAX312-596-4187
  3. Cincinnati District Office
    1. District Director, HFR-CE400.513-679-2700 x116
      • Director Compliance Branch HFR-CE440 513-679-2700 x160
      • FAX 513-679-2775
  4. Detroit District Office
    1. District Director, HFR-CE700313-393-8106
      • Director Compliance Branch, HFR-CE740 313-393-8110
      • FAX 313-393-8139
  5. Forensic Chemistry Center
    1. Director, HFR-CE500513-679-2700  x180
    2. FAX 513-679-2761
  6. Minneapolis District Office
    1. District Director, HFR-CE800612-334-4100
      • Director Compliance Branch, HFR-CE840 612-758-7112
      • FAX612-334-4134
  7. New Jersey District Office
    1. District Director, HFR-CE300 973-331-4901
      • Director Compliance Branch, HFR-CE340 973-331-4902
      • FAX973-331-4969
  8. Philadelphia District Office
    1. District Director, HFR-CE100 215-717-3001
      • Director Compliance Branch, HFR-CE140 215-717-3071
      • FAX215-597-8212
Southeast Region
  1. Regional Food and Drug Director, HFR-SE1 404-253-1171
  2. FAX 404-253-1207
  1. Atlanta District Office
    1. District Director, HFR-SE100 404-253-1161
      • Director Compliance Branch, HFR-SE140 404-253-1163
      • FAX 404-253-1201
  2. Florida District Office
    1. District Director, HFR-SE200 407-475-4701
      • Director Compliance Branch, HFR-SE240 407-475-4734
      • FAX 407-475-4769
  3. New Orleans District Office
    1. District Director, HFR-SE400 615-366-7803
      • Director Compliance Branch, HFR-SE440 504-219-8818 x101
      • FAX504-219-8813
  4. San Juan District Office
    1. District Director, HFR-SE500 787-474-9565
      • Director Compliance Branch, HFR-SE540 787-474-9565
      • FAX 787-729-6658
  5. Southeast Regional Laboratory
    1. Director, HFR-SE600 404-253-1176
    2. FAX 404-253-1208
Southwest Region
  1. Regional Food and Drug Director, HFR-SW1214-253-4904
  2. FAX214-253-4965
  1. Arkansas Regional Laboratory
    1. Director, HFR-SW500870-543-4099
    2. FAX 870-543-4002
  2. Dallas District Office
    1. District Director, HFR-SW100214-253-5201
    2. Director Compliance Branch, HFR-SW140 214-253-5215
    3. FAX214-253-5314
  3. Denver District Office
    1. District Director, HFR-SW200 303-236-3016
    2. Director Compliance Branch, HFR-SW240303-236-3019
    3. FAX 303-236-3551
  4. Kansas City District Office
    1. District Director, HFR-SW300913-752-2144
    2. Director Compliance Branch, HFR-SW340913-752-2101
    3. FAX 913-752-2111
  5. Southwest Import District Office
    1. Director, HFR-SW600214-253-5283
    2. Director Compliance Branch, HFR-SW640 214-253-5284
    3. FAX214-253-5316
Pacific Region
  1. Regional Food and Drug Director, HFR-PA1510-637-3960 x118
  2. FAX 510-637-3976
  1. Los Angeles District Office
    1. District Director, HFR-PA200949-608-4414
    2. Director Compliance Branch, HFR-PA240 949-608-4426
    3. FAX 949-608-4415
  2. San Francisco District Office
    1. District Director, HFR-PA100 510-337-6783
    2. Director Compliance Branch, HFR-PA140510-337-6769
    3. FAX510-337-6703
  3. Seattle District Office
    1. District Director, HFR-PA300 425-483-4950
    2. FAX425-483-4989
    3. Director Compliance Branch, HFR-PA340425-483-4912
    4. FAX 425-483-4760
  4. Pacific Regional Laboratory Northwest
    1. Director, HFR-PA360 425-486-8788
    2. FAX 425-483-4996
  5. Pacific Regional Laboratory Southwest
    1. Director, HFR-PA260 949-608-2907
    2. FAX 949-608-3567

 1-9-3 - FDA Centers

Center For Biologics Evaluation And Research (CBER)
  1. Director, Office of Compliance and Biologics Quality, HFM-600 301-827-6190
  2. Deputy Director, Office of Compliance and Biologics Quality, HFM-600 301-827-6190
    1. Director, Division of Case Management, HFM-610 301-827-6201
    2. Director, Division of Inspections and Surveillance, HFM-650 301-827-6220
    3. Director, Division of Manufacturing and Product Quality, HFM-670 301-827-3031
    4. Director, Division of Product Quality, HFM-680 301-594-0847
Center For Drug Evaluation And Research (CDER)
  1. Director, Office of Compliance 301-796-3100
    1. Associate Director of Scientific & Medical Affairs 301-796-3100
    2. Deputy Director, Office of Compliance301-796-3100
    3. Assistant Director 301-796-3100
    4. Director, Division of New Drugs and Labeling Compliance 301-796-3110
      • Deputy Director301-796-3110
      • Associate Director 301-796-3110
      • OTC Drugs Team301-796-3110
      • Internet and Health Fraud Team301-796-3110
      • Compounding Team301-796-3110
      • New Drugs and Labeling Team301-796-3110
      • Imports and Exports Team301-796-3110
    5. Director, Division of Manufacturing and Product Quality 301-796-3120
      • Deputy Director301-796-3120
      • Recalls and Shortages Branch 301-796-3120
      • Manufacturing Assessment & Pre-Approval Compliance Branch301-796-3120
      • New & Generic Drug Manufacturing Team301-796-3120
      • International Compliance Team301-796-3120
      • Biotech Manufacturing Team301-796-3120
      • Domestic Case Management & Guidance Branch301-796-3120
      • Domestic Case Management Team 301-796-3120
      • International Compliance Branch301-796-3120
      • Guidance and Policy Development Team 301-796-3120
    6. Director, Division of Compliance Risk Management & Surveillance 301-796-3130
      • Deputy Director301-796-3130
      • Risk Management and Strategic Problem Solving Team 301-796-3130
      • Surveillance and Data Analysis Branch301-796-3130
      • Surveillance Programs Team 301-796-3130
      • Data Analysis & Information Management Team301-796-3130
      • Drug Registration & Listing Team301-796-3130
    7. Director, Division of Scientific Investigations301-796-3150
      • Deputy Director301-796-3150
      • Good Clinical Practice Branch 1301-796-3150
      • Good Clinical Practice Branch 2301-796-3150
      • Human Subjects Protections Team301-796-3150
      • Good Laboratory Practices Bioequivalence Branch .301-796-3150
      • Informatics and Infrastructure Team301-796-3150
      • International Policy Team301-796-3150
      • Enforcement Policy Team301-796-3150
Center For Devices And Radiological Health (CDRH)
  1. Director, Office of Compliance, WO66, 3521301-796-5500
    1. Deputy Director for Regulatory Affairs, Office of Compliance 301-796-5500
    2. Deputy Director for Medical Affairs, Office of Compliance 301-796-5800
    3. Director, Division of Risk Management Operations, WO66, 3521301-796-5530
    4. Deputy Director, Division of Risk Management Operations 301-796-5530
      • Chief, Recall Branch 301-796-5792
      • Chief, Field Operations Branch 301-796-5812
      • Chief, Regulatory Policy and Systems Branch301-796-5615
    5. Director, Division of Bioresearch Monitoring, WO66, 3446301-796-5490
      • Chief, Program Enforcement Branch A 301-796-5654
      • Chief, Program Enforcement Branch B 301-796-6054
      • Chief, Special Investigations Branch 301-796-6561
    6. Director, Division of Enforcement A, WO66, 3512301-796-5770
      • Deputy Director, Division of Enforcement A .301-796-5770
      • Lead CSO 301-796-5770
      • Chief, General Surgical Devices Branch 301-796-5462
      • Chief, Dental, ENT and Ophthalmic Devices Branch 301-796-5770
      • Chief, OB/GYN, Gastroenterology and Urology Devices Branch 301-796-5484
      • Chief, General Hospital Devices Branch301-796-5770
    7. Director, Division of Enforcement B, WO66, 3656 301-796-5540
      • Deputy Director, Division of Enforcement B 301-796-5540
      • Lead CSO 301-796-5593
      • Software Expert 301-796-5543
      • Chief, Cardiac Rhythm and Electrophysiology Devices Branch 301-796-5540
      • Chief, Vascular and Circulatory Support Devices Branch 301-796-5540
      • Chief, Orthopedic and Physical Medicine Devices Branch 301-796-5588
      • Radiology, Anesthesiology, and Neurology Devices Branch 301-796-5540
  2. Director, Office of In Vitro Diagnostic Device Evaluation and Safety, WO66, 5680 301-796-5453
    1. Deputy Director, Patient Safety and Product Quality 301-796-6225
    2. Deputy Director, New Product Evaluation301-796-5454
  3. Director, Office of Communication, Education and Radiation Programs, WO66 4312 301-796-5716
    1. Director, Division of Mammography Quality and Radiation Programs, WO66 4680 301-796-5713
      • Chief, Electronic Products Branch 301-796-5863
      • Chief, Diagnostic X-Ray Devices Branch 301-796-5895
      • Chief, Inspection and Compliance Branch 301-796-5911
Center For Food Safety And Applied Nutrition (CFSAN)
  1. Director, Office of Compliance (OC), HFS-600 240-402-2359
    1. Special Advisor (OC), HFS-600 240-402-2030
    2. Deputy Director (OC), HFS-600 Vacant
    3. Division of Enforcement, HFS-605 240-402-1750
      • Recall Team, HFS-605 240-402-1742
      • Manufacturing and Storage Adulteration Branch, HFS-607 240-402-1611
      • Labeling Compliance Team, HFS-608 240-402-2148
      • Product Adulteration Branch, HFS-606 240-402-2349
    4. Division of Field Programs and Guidance, HFS-615 240-402-1988
      • Field Programs Branch240-402-2774
      • Compliance Information Branch 240-402-1910
  2. Director, Office of Cosmetics and Colors (OCAC), HFS-100 240-402-1130
    1. Deputy Director (OCAC)240-402-1130
    2. Cosmetics Staff, HFS-125 240-402-1124
      • Cosmetics Activities Team, HFS-320Vacant
      •  
    3. Division of Color Certification and Technology, HFS-105240-402-1108
      • Color Technology Team, HFS-106240-402-1136
      • Color Certification Branch, HFS-107240-402-1119
  3. Director, Office of Nutrition, Labeling and Dietary Supplements, HFS-800240-402-2373
    1. Deputy Director (ONLDS), HFS-800 240-402-1761
    2. Food Labeling and Standards Staff, HFS-820240-402-2371
      • Product Evaluation and Labeling Team, HFS-820 240-402-1802
      • Labeling Regulations Implementation Team, HFS-820 240-402-1690
    3. Nutrition Programs Staff, HFS-830 240-402-1450
      • Nutrition Assessment and Evaluation Team, HFS-830240-402-1788
      • Nutrition Science Review Team, HFS-830240-402-2579
    4. Division of Dietary Supplement Programs, HFS-810240-402-1850
      • Clinical Evaluation Team Vacant
      • Dietary Supplement Regulations Implementation Team, HFS-810 240-402-1441
      • NDI Review Staff, HFS-810240-402-2851
    5. Infant Formula and Medical Foods Staff, HFS-850 240-402-1459
  4. Director, Office of Food Safety (OFS), HFS-300240-402-1700
    1. Deputy Director (OFS), HFS-300 240-402-2300
    2. Chemical Hazard Assessment Team, HFS-301240-402-1941
    3. Food Processing Evaluation Team, HFS-302240-402-1781
    4. Division of Seafood Science and Technology, HFS-400251-690-3368
      • Chemical Hazards Science Branch, HFS-400 215-690-3403
      • Microbiological Hazards Science Branch, HFS-400251-690-3361
    5. Division of Food Processing Science and Technology, HFS-450708-728-4154
      • Process Engineering Branch, HFS-450708-728-4131
      • Food Technology Branch, HFS-450 708-728-4146
      • Laboratory Proficiency and Evaluation Team, HFS-450 708-728-4114
    6. Division of Plant and Dairy Food Safety, HFS-315240-402-1488
      • Dairy and Egg Branch, HFS-316240-402-2041
      • Plant Products Branch, HFS-317240-402-2023
    7. Retail Food & Cooperative Programs Coordination Staff, HFS-320 240-402-2149
      • Retail Food Protection Team, HFS-320 240-402-2150
      •  
    8. Produce Safety Staff, HFS-317240-402-1636
    9. Division of Seafood Safety, HFS-325 240-402-1422
      • Shellfish & Aquaculture Policy Branch, HFS-325 240-402-1401
      • Seafood Processing and Technology Policy Branch, HFS-325 240-402-1420
  5. Director, Office of Regulatory Science (ORS), HFS-700240-402-1990
    1. Deputy Director (ORS), HFS-700 240-402-1908
    2. Division of Analytical Chemistry, HFS-705 240-402-1898
      • Methods Development Branch 240-402-1893
      • Spectroscopy & Mass Spectrometry Branch 240-402-2039
    3. Division of Microbiology, HFS-710Vacant
      • Microbial Methods Development Branch, HFS-711 240-402-2009
      • Molecular Methods and Subtyping Branch 240-402-2020
    4. Division of Bioanalytical Chemistry, HFS-715 240-402-1786
      • Chemical Contaminants Branch, HFS-716 240-402-2003
      • Bioanalytical Methods Branch240-402-2098
Center For Veterinary Medicine (CVM)
  1. Director, Office of Surveillance and Compliance (OS &C), HFV-200 240-453-6830
  2. Deputy Director, OS&C, HFV-200240-453-6830
    1. Director, Division of Surveillance, HFV-210 240-276-9062
      • Team Leader, Marketed Product Information Team, HFV-212240-276-9075
      • Team Leader, Unapproved Hazard and Jurisdictional Review Team, HFV-214 240-276-9063
      • Team Leader, Post-Approval Review Team, HFV-216 240-453-6802
    2. Director, Division of Animal Feeds, HFV-220240-453-6864
      • Team Leader, Feed Safety Team, HFV-222240-453-6851
      • Team Leader, Ingredient Safety Team, HFV-224240-453-6879
      • Team Leader, Medicated Feeds Team, HFV-226 240-453-6858
      • Team Leader, Nutrition and Labeling Team, HFV-228 240-453-6866
    3. Director, Division of Compliance, HFV-230 240-276-9200
      • Team Leader, Complaint/Emergency/Recall Team, HFV-231240-276-9237
      • Team Leader, Post-Market Compliance Team, HFV-232240-276-9204
      • Team Leader, Drug Residue Compliance Team, HFV-233240-276-9209
      • Team Leader, Pre-Market Compliance and Administrative Actions Team, HFV-234240-276-9238
      • Team Leader, Programs and Operations Support Team, HFV-235240-276-9209
    4. Director, Division of Veterinary Product Safety HFV-240 240-453-6844
      • Team Leader, Adverse Drug Event Review Team, HFV-241240-276-9068
      • Team Leader, Adverse Event Review Team, HFV-242240-276-9056
      • Team Leader, Data Management and Analysis Team, HFV-243240-276-9071
Center For Tobacco Products (CTP)
  1. Director, Office of Compliance and Enforcement301-796-5503
    1. Deputy Director301-796-8725
    2. ORA Liaison, General Inquiries301-796-9296
    3. Group Leader, Enforcement and Manufacturing 301-796-9220
    4. Group Leader, Promotion, Advertising and Labeling Compliance301-796-9235
    5. Group Leader, State Programs301-796-9220

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