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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

1. Associate Commissioner for Regulatory Affairs (ACRA)
ACRA 301-796-8800
  1. Deputy Associate Commissioner for Regulatory Affairs (DACRA)301-796-8310
2. Office of Enforcement and Import Operations (OEIO)301-796-5270
  1. Office Directorvacant
  2. Deputy Direrctor301-796-5723
  1. Director, Division of Import Operations (DIO)301-796-0356
    1. Chief, Import Operations and Maintenance Branchvacant
    2. Chief, Import Program Development and Implementation Branch301-796-6677
  2. Division of Compliance Systems (DCS)/Enforcement Systems Branch (ESB)
    1. Directorvacant
    2. Chief, Enforcement Systems Branch301-796-3240
    3. Chief, Import Compliance Systems Branch301-796-8997
  3. Division of Enforcement (DE)
    1. Director301-796-8203
    2. Deputy Director301-796-8206
  4. Division of Import Operations
    Import Alerts and bulletins
    Import filer evaluation
    program
    Foreign Supplier Verification
    program
  5. Division of Compliance Systems/Enforcement Systems Branch
    Electronic Regulatory Information Quality Assurance
    Government-wide Quality Assurance Program
    Federal Medical Products Quality Assurance Program
    ORA systems (CMS, MARCS, Citations database, COMSTAT)
    Compliance Information & Reporting
    Turbo EIR
    Health Communications
  6. Division of Enforcement
    Case Review and Management
    Civil Money Penalties (Compliance)
    Inspection Warrants
    Recalls
    Team Biologics (Compliance)
    Warning Letter Database
    Health fraud
    Debarment
3. Office of Operations (OO)
  1. Assistant Commissioner for Operationsvacant
    1. Audit Staff Directorvacant
4. Office of Policy and Risk Management (OPRM)
Compliance Policy Council
Compliance Policy Guides
Regulatory Procedures Manual
Testimony
Federal Register Regulations
Intra-agency Enforcement Policy
Program Planning and Evaluation
Program Evaluation
Work Planning
Policy (Food and Feed)
Policy (Medical Products and Tobacco)
Risk Management
  1. Assistant Commissioner for policy301-796-8211
  2. Deputy Director301-796-8805
5. Office of Criminal Investigations (OCI)
  1. Director, OCI240-276-9460

 

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

1. Northeast Region
  1. Regional Food and Drug Director, HFR-NE1781-587-7533
    FAX781-587-7556
    Deputy Regional Food and Drug Director, HFR-NE2718-662-5610
    FAX718-662-5434
  2. New York District Office718-340-7000
    1. District Director, HFR-100718-662-5447
      FAX781-662-5665
      • Director Compliance Branch
        HFR-NE340716-551-4461 Ext 3116
        FAX716-551-4499
  3. New England District Office781-587-7500
    1. District Director, HFR-NE200781-587-7490
      FAX781-587-7556
      • Director Compliance Branch, HFR-NE240781-587-7488
        FAX781-587-7556
  4. Winchester Engineering & Analytical Center781-756-9700
    1. Director, HFR-NE400781-756-9701
      FAX781-756-9757
  5. Northeast Regional Laboratory
    1. Director, HFR-NE500718-662-5450
      FAX718-662-5439
2. Central Region
  1. Regional Food and Drug Director, CHI-FO, HFR-CE1312-596-6501
    FAX312-886-1682
  2. Deputy Regional Food and Drug Director, PHI-FO
    HFR-CE2215-717-3701
    FAX215-597-5798
  3. Baltimore District Office
    1. District Director, HFR-CE200410-779-5424
      • Director Compliance Branch, HFR-CE240410-779-5417
        FAX410-779-5707
  4. Chicago District Office
    1. District Director, HFR-CE600312-596-4200
      • Director Compliance Branch, HFR-CE640312-596-4220
        FAX312-596-4187
  5. Cincinnati District Office
    1. District Director, HFR-CE400513-679-2700 Ext 116
      • Director Compliance Branch, HFR-CE440513-679-2700 Ext 160
        FAX513-679-2775
  6. Detroit District Office
    1. District Director, HFR-CE700313-393-8106
      • Director Compliance Branch, HFR-CE740313-393-8110
        FAX313-393-8139
  7. Forensic Chemistry Center
    1. Director, HFR-CE500513-679-2700 Ext 180
      FAX513-679-2761
  8. Minneapolis District Office
    1. District Director, HFR-CE800612-334-4100
      • Director Compliance Branch, HFR-CE840612-758-7112
        FAX612-334-4134
  9. New Jersey District Office
    1. District Director, HFR-CE300973-331-4901
      • Director Compliance Branch, HFR-CE340973-331-4902
        FAX973-331-4969
  10. Philadelphia District Office
    1. District Director, HFR-CE100215-717-3001
      • Director Compliance Branch, HFR-CE140215-717-3071
        FAX215-597-8212
3. Southeast Region
  1. Regional Food and Drug Director, HFR-SE1404-253-1171
    FAX404-253-1207
  2. Atlanta District Office
    1. District Director, HFR-SE100404-253-1161
      • Director Compliance Branch, HFR-SE140404-253-1163
        FAX404-253-1201
  3. Florida District Office
    1. District Director, HFR-SE200407-475-4701
      • Director Compliance Branch, HFR-SE240407-475-4734
        FAX407-475-4769
  4. New Orleans District Office
    1. District Director, HFR-SE400615-366-7803
      • Director Compliance Branch, HFR-SE440615-366-7988
        FAX615-366-7805
  5. San Juan District Office
    1. District Director, HFR-SE500787-474-9565
      • Director Compliance Branch, HFR-SE540787-474-9565
        FAX787-729-6658
  6. Southeast Regional Laboratory
    1. Director, HFR-SE600404-253-1170
      FAX404-253-1208
4. Southwest Region
  1. Regional Food and Drug Director, HFR-SW1214-253-4904
    FAX214-253-4965
  2. Arkansas Regional Laboratory
    1. Director, HFR-SW500870-543-4099
      FAX870-543-4002
  3. Dallas District Office
    1. District Director, HFR-SW100214-253-5201
    2. Director Compliance Branch, HFR-SW140214-253-5215
      FAX214-253-5314
  4. Denver District Office
    1. District Director, HFR-SW200303-236-3016
    2. Director Compliance Branch, HFR-SW240303-263-3019
      FAX303-236-3551
  5. Kansas City District Office
    1. District Director, HFR-SW300913-752-2144
    2. Director Compliance Branch, HFR-SW340913-752-2101
      FAX913-752-2111
  6. Southwest Import District Office
    1. Director, HFR-SW600214-253-5283
    2. Director Compliance Branch, HFR-SW640214-253-5284
      FAX214-253-5316
5. Pacific Region
  1. Regional Food and Drug Director, HFR-PA1510-637-3960 Ext 118
    FAX510-637-3976
  2. Los Angeles District Office
    1. District Director, HFR-PA200949-608-4414
    2. Director Compliance Branch, HFR-PA240949-608-4426
      FAX949-608-4415
  3. San Francisco District Office
    1. District Director, HFR-PA100510-337-6783
    2. Director Compliance Branch, HFR-PA140510-337-6769
      FAX510-337-6703
  4. Seattle District Office
    1. District Director, HFR-PA300425-483-4950
      FAX425-483-4989
    2. Director Compliance Branch, HFR-PA340425-483-4912
      FAX425-483-4760
  5. Pacific Regional Laboratory Northwest
    1. Director, HFR-PA360425-486-8788
      FAX425-483-4996
  6. Pacific Regional Laboratory Southwest
    1. Director, HFR-PA260949-608-2907
      FAX949-608-3567

 

 1-9-3 - FDA Centers

Center for Biologics Evaluation And Research (CBER)
  1. Director, Office of Compliance and Biologics Quality, HFM-600301-827-6190
  2. Deputy Director, Office of Compliance and Biologics Quality, HFM-600301-827-6190
    1. Director, Division of Case Management, HFM-610301-827-6201
    2. Director, Division of Inspections and Surveillance, HFM-650301-827-6220
    3. Director, Division of Manufacturing and Product Quality, HFM-670301-827-3031
    4. Director, Division of Biological Standards and Quality Control, HFM-680301-594-6299
Center for Drug Evaluation And Research (CDER)
  1. Director, Office of Compliance301-796-3100
    1. Deputy Directors301-796-3100
    2. Associate Directors301-796-3100
    3. Director, Office of Unapproved Drugs and Labeling Compliance301-796-3100
      • Deputy Director301-796-3100
      • Assistant Directors301-796-3100
      • Division of Prescription Drugs301-796-3110
      • Division of Non-Prescription Drugs301-796-3110
    4. Director, Office of Manufacturing and Product Quality301-796-3120
      • Deputy Director301-796-3120
      • Regulatory Policy and Collaboration Branch301-796-3120
      • Division of Good Manufacturing Practice Assessment301-796-3120
      • New Drug Manufacturing Assessment Branch301-796-3120
      • Division of International Drug Quality301-796-3120
      • Biotech Manufacturing Assessment Branch301-796-3120
      • Division of Domestic Drug Quality301-796-3120
      • Drug Surveillance and Data Reporting Branch301-796-3120
      • Generic Drug Manufacturing Assessment Branch301-796-3120
      • Division of Policy, Collaboration and Data Operations301-796-3120
    5. Director, Office of Drug Security, Integrity and Recalls301-796-3130
      • Deputy Director301-796-3130
      • Associate Directors301-796-3130
      • Division of Import Operations and Recalls301-796-3130
      • Division of Supply Chain Integrity301-796-3130
    6. Director, Office of Scientific Investigations301-796-3150
      • Deputy Director301-796-3150
      • Division of Good Clinical Practice Compliance301-796-3150
      • Division of Safety Compliance301-796-3150
      • Division of Bioequivalence and Good Laboratory Practice301-796-3150
      • Program Management and Organization Strategy301-796-3150
      • Risk Science, Intelligence and Prioritization301-796-3150
      • Outreach and Collaboration 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 Compliance301-796-5500
    2. Deputy Director for Medical Affairs, Office of Compliance301-796-5800
    3. Director, Division of Risk Management Operations, WO66, 3521301-796-5530
    4. Deputy Director, Division of Risk Management Operations301-796-5530
      • Chief, Recall Branch301-796-5792
      • Chief, Field Operations Branch301-796-5812
      • Chief, Regulatory Policy and Systems Branch301-796-5615
    5. Director, Division of Bioresearch Monitoring, WO66, 3446301-796-5490
      • Chief, Program Enforcement Branch A301-796-5654
      • Chief, Program Enforcement Branch B301-796-6054
      • Chief, Special Investigations Branch301-796-6561
    6. Director, Division of Enforcement A, WO66, 3512301-796-5770
      • Deputy Director, Division of Enforcement A301-796-5770
      • Lead CSO301-796-5770
      • Chief, General Surgical Devices Branch301-796-5462
      • Chief, Dental, ENT and Ophthalmic Devices Branch301-796-5770
      • Chief, OB/GYN, Gastroenterology and Urology Devices Branch301-796-5484
      • Chief, General Hospital Devices Branch301-796-5770
    7. Director, Division of Enforcement B, WO66, 3656301-796-5540
      • Deputy Director, Division of Enforcement B301-796-5540
      • Lead CSO301-796-5593
      • Software Expert301-796-5543
      • Chief, Cardiac Rhythm and Electrophysiology Devices Branch301-796-5540
      • Chief, Vascular and Circulatory Support Devices Branch301-796-5540
      • Chief, Orthopedic and Physical Medicine Devices Branch301-796-5588
      • Radiology, Anesthesiology, and Neurology Devices Branch301-796-5540
  2. Director, Office of In Vitro Diagnostic Device Evaluation and Safety, WO66, 5680301-796-5453
    1. Deputy Director, Patient Safety and Product Quality301-796-6225
    2. Deputy Director, New Product Evaluation301-796-5454
  3. Director, Office of Communication, Education and Radiation Programs, WO66 4312301-796-5716
    1. Director, Division of Mammography Quality and Radiation Programs, WO66 4680301-796-5713
      • Chief, Electronic Products Branch301-796-5863
      • Chief, Diagnostic X-Ray Devices Branch301-796-5895
      • Chief, Inspection and Compliance Branch301-796-5911
Center for Food Safety And Applied Nutrition (CFSAN)
  1. Director, Office of Compliance (OC), HFS-600240-402-2359
    1. Deputy Director (OC), HFS-600240-402-1364
    2. Division of Enforcement, HFS-605240-402-1750
      • Recall and Product Reconditioning Team, HFS-605240-402-1742
      • Food Adulteration Assessment Branch, HFS-607240-402-1611
      • Labeling and Dietary Supplement Compliance Team, HFS-608240-402-2148
    3. Division of Field Programs and Guidance, HFS-615240-402-1988
      • Field Programs Branch240-402-2774
      • Compliance Information Branch240-402-1910
  2. Director, Office of Cosmetics and Colors (OCAC), HFS-100240-402-1130
    1. Cosmetics Staff, HFS-125240-402-1124
    2. Division of Color Certification and Technology, HFS-105240-402-1108
  3. Director, Office of Nutrition, Labeling and Dietary Supplements, HFS-800vacant
    1. Deputy Director (ONLDS), HFS-800240-402-1761
    2. Food Labeling and Standards Staff, HFS-820240-402-2371
    3. Nutrition Programs Staff, HFS-830240-402-1450
    4. Division of Dietary Supplement Programs, HFS-810240-402-1850
    5. Infant Formula and Medical Foods Staff, HFS-850240-402-1459
  4. Director, Office of Food Safety (OFS), HFS-300240-402-1700
    1. Deputy Director (OFS), HFS-300vacant
    2. Food Processing Evaluation Team, HFS-302240-402-1781
    3. Division of Seafood Science and Technology, HFS-400251-690-3368
    4. Division of Food Processing Science and Technology, HFS-450708-728-4154
    5. Division of Plant and Dairy Food Safety, HFS-315240-402-1488
    6. Retail Food & Cooperative Programs Coordination Staff, HFS-320240-402-2149
    7. Produce Safety Staff, HFS-317240-402-1636
    8. Division of Seafood Safety, HFS-325240-402-1422
  5. Director, Office of Regulatory Science (ORS), HFS-700vacant
    1. Deputy Director (ORS), HFS-700240-402-1908
    2. Division of Analytical Chemistry, HFS-705240-402-1898
    3. Division of Microbiology, HFS-710240-402-2020
    4. Division of Bioanalytical Chemistry, HFS-715240-402-1786
Center for Veterinary Medicine (CVM)
  1. Director, Office of Surveillance and Compliance (OS &C), HFV-200240-453-6830
  2. Deputy Director, OS&C, HFV-200240-453-6830
    1. Director, Division of Surveillance, HFV-210240-276-9062
      • Team Leader, Marketed Product Information Team, HFV-212240-276-9075
      • Team Leader, Unapproved Hazard and Jurisdictional Review Team, HFV-214240-276-9063
      • Team Leader, Post-Approval Review Team, HFV-216240-453-6802
    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-226240-453-6858
      • Team Leader, Nutrition and Labeling Team, HFV-228240-453-6866
    3. Director, Division of Compliance, HFV-230240-276-9200
      • 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-240240-453-6844
      • 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 Enforcement (OCE)301-796-9295
    1. Deputy Director301-796-8569
    2. ORA Liaison, General Inquiries301-796-9338
    3. Director, Division of Enforcement and Manufacturing301-796-5533
    4. Director, Division of Promotion, Advertising and Labeling Compliance301-796-9235
    5. Director, Division of State Programs301-796-9297