Inspections, Compliance, Enforcement, and Criminal Investigations

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 Phone Numbers

1. Associate Commissioner for Regulatory Affairs (ACRA)

ACRA

Deputy Associate Commissioner for Regulatory Affairs (DACRA)

301-796-8800

301-796-8310

2. Office of Enforcement and Import Operations (OEIO)

301-796-5270
Office Director vacant
Deputy Director 301-796-5723

Director, Division of Import Operations (DIO)

Chief, Import Operations and Maintenance Branch
Chief, Import Program Development and Implementation Branch

301-796-0356

vacant
301-796-6677

Division of Compliance Systems (DCS)/Enforcement Systems Branch (ESB)

Director
Chief, Enforcement Systems Branch
Chief, Import Compliance Systems Branch

 

vacant
301-796-3240
301-796-8997

Division of Enforcement (DE)

Director
Deputy Director

 

301-796-8203
301-796-8206

Division of Import Operations
Import Alerts and bulletins
Import filer evaluation program
Foreign Supplier Verification program
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
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)

Assistant Commissioner for Operations

Audit Staff Director

vacant

vacant

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

Assistant Commissioner for policy
Deputy Director

 

301-796-8211
301-796-8805

5. Office of Criminal Investigations (OCI)

Director, OCI

240-276-9460
1-9-2 - Office of Regulatory Affairs - Field Phone Numbers

1. Northeast Region

Regional Food and Drug Director, HFR-NE1
FAX
781-587-7533
781-587-7556
Deputy Regional Food and Drug Director, HFR-NE2
FAX
718-662-5610
718-662-5434

New York District Office

District Director, HFR-100
FAX

Director Compliance Branch, HFR-NE340
FAX

718-340-7000

718-662-5447
781-662-5665

716-551-4461 Ext 3116
716-551-4499

New England District Office

District Director, HFR-NE200
FAX

Director Compliance Branch, HFR-NE240
FAX

781-587-7500

781-587-7490
781-587-7556

781-587-7488
781-587-7556

Winchester Engineering & Analytical Center

Director, HFR-NE400
FAX

781-756-9700

781-756-9701
781-756-9757

Northeast Regional Laboratory

Director, HFR-NE500
FAX

 

718-662-5450
718-662-5439

2. Central Region

Regional Food and Drug Director, CHI-FO, HFR-CE1
FAX
312-596-6501
312-886-1682

Deputy Regional Food and Drug Director, PHI-FO
HFR-CE2
FAX

 

215-717-3701
215-597-5798

Baltimore District Office

District Director, HFR-CE200
Director Compliance Branch, HFR-CE240
FAX

 

410-779-5424
410-779-5417
410-779-5707

Chicago District Office

District Director, HFR-CE600
Director Compliance Branch, HFR-CE640
FAX

 

312-596-4200
312-596-4220
312-596-4187

Cincinnati District Office

District Director, HFR-CE400
Director Compliance Branch, HFR-CE440
FAX

 

513-679-2700 Ext 116
513-679-2700 Ext 160
513-679-2775

Detroit District Office

District Director, HFR-CE700
Director Compliance Branch, HFR-CE740
FAX

 

313-393-8106
313-393-8110
313-393-8139

Forensic Chemistry Center

Director, HFR-CE500
FAX

 

513-679-2700 Ext 180
513-679-2761

Minneapolis District Office

District Director, HFR-CE800
Director Compliance Branch, HFR-CE840
FAX

 

612-334-4100
612-758-7112
612-334-4134

New Jersey District Office

District Director, HFR-CE300
Director Compliance Branch, HFR-CE340
FAX

 

973-331-4901
973-331-4902
973-331-4969

Philadelphia District Office

District Director, HFR-CE100
Director Compliance Branch, HFR-CE140
FAX

 

215-717-3001
215-717-3071
215-597-8212

3. Southeast Region

Regional Food and Drug Director, HFR-SE1
FAX
404-253-1171
404-253-1207

Atlanta District Office

District Director, HFR-SE100
Director Compliance Branch, HFR-SE140
FAX

 

404-253-1161
404-253-1163
404-253-1201

Florida District Office

District Director, HFR-SE200
Director Compliance Branch, HFR-SE240
FAX

 

407-475-4701
407-475-4734
407-475-4769

New Orleans District Office

District Director, HFR-SE400
Director Compliance Branch, HFR-SE440
FAX

 

615-366-7803
615-366-7988
615-366-7805

San Juan District Office

District Director, HFR-SE500
Director Compliance Branch, HFR-SE540
FAX

 

787-474-9565
787-474-9565
787-729-6658

Southeast Regional Laboratory

Director, HFR-SE600
FAX

 

404-253-1170
404-253-1208

4. Southwest Region

Regional Food and Drug Director, HFR-SW1
FAX
214-253-4904
214-253-4965

Arkansas Regional Laboratory

Director, HFR-SW500
FAX

 

870-543-4099
870-543-4002

Dallas District Office

District Director, HFR-SW100
Director Compliance Branch, HFR-SW140
FAX

 

214-253-5201
214-253-5215
214-253-5314

Denver District Office

District Director, HFR-SW200
Director Compliance Branch, HFR-SW240
FAX

 

303-236-3016
303-263-3019
303-236-3551

Kansas City District Office

District Director, HFR-SW300
Director Compliance Branch, HFR-SW340
FAX

 

913-752-2144
913-752-2101
913-752-2111

Southwest Import District Office

Director, HFR-SW600
Director Compliance Branch, HFR-SW640
FAX

 

214-253-5283
214-253-5284
214-253-5316

5. Pacific Region

Regional Food and Drug Director, HFR-PA1
FAX
510-637-3960 Ext 118
510-637-3976

Los Angeles District Office

District Director, HFR-PA200
Director Compliance Branch, HFR-PA240
FAX

 

949-608-4414
949-608-4426
949-608-4415

San Francisco District Office

District Director, HFR-PA100
Director Compliance Branch, HFR-PA140
FAX

 

510-337-6783
510-337-6769
510-337-6703

Seattle District Office

District Director, HFR-PA300
FAX

Director Compliance Branch, HFR-PA340
FAX

 

425-483-4950
425-483-4989

425-483-4912
425-483-4760

Pacific Regional Laboratory Northwest

Director, HFR-PA360
FAX

 

425-486-8788
425-483-4996

Pacific Regional Laboratory Southwest

Director, HFR-PA260
FAX

 

949-608-2907
949-608-3567

1-9-3 - FDA Centers Phone Numbers

Center for Biologics Evaluation And Research (CBER)

Director, Office of Compliance and Biologics Quality, HFM-600 301-827-6190
Deputy Director, Office of Compliance and Biologics Quality, HFM-600 301-827-6190

Director, Division of Case Management, HFM-610

301-827-6201

Director, Division of Inspections and Surveillance, HFM-650

301-827-6220

Director, Division of Manufacturing and Product Quality, HFM-670

301-827-3031

Director, Division of Biological Standards and Quality Control, HFM-680

301-594-6299

Center for Drug Evaluation And Research (CDER)

Director, Office of Compliance 301-796-3100
Deputy Directors 301-796-3100
Associate Directors 301-796-3100
Director, Office of Unapproved Drugs and Labeling Compliance 301-796-3100

Deputy Director

301-796-3100

Assistant Directors

301-796-3100

Division of Prescription Drugs

301-796-3110

Division of Non-Prescription Drugs

301-796-3110
Director, Office of Manufacturing and Product Quality 301-796-3120

Deputy Director

301-796-3120

Regulatory Policy and Collaboration Branch

301-796-3120

Division of Good Manufacturing Practice Assessment

301-796-3120

New Drug Manufacturing Assessment Branch

301-796-3120

Division of International Drug Quality

301-796-3120

Biotech Manufacturing Assessment Branch

301-796-3120

Division of Domestic Drug Quality

301-796-3120

Drug Surveillance and Data Reporting Branch

301-796-3120

Generic Drug Manufacturing Assessment Branch

301-796-3120

Division of Policy, Collaboration and Data Operations

301-796-3120
Director, Office of Drug Security, Integrity and Recalls 301-796-3130

Deputy Director

301-796-3130

Associate Directors

301-796-3130

Division of Import Operations and Recalls

301-796-3130

Division of Supply Chain Integrity

301-796-3130
Director, Office of Scientific Investigations 301-796-3150

Deputy Director

301-796-3150

Division of Good Clinical Practice Compliance

301-796-3150

Division of Safety Compliance

301-796-3150

Division of Bioequivalence and Good Laboratory Practice

301-796-3150

Program Management and Organization Strategy

301-796-3150

Risk Science, Intelligence and Prioritization

301-796-3150

Outreach and Collaboration Team

301-796-3150

Enforcement Policy Team

301-796-3150

Center for Devices And Radiological Health (CDRH)

Director, Office of Compliance, WO66, 3521 301-796-5500
Deputy Director for Regulatory Affairs, Office of Compliance 301-796-5500
Deputy Director for Medical Affairs, Office of Compliance 301-796-5800
Director, Division of Risk Management Operations, WO66, 3521 301-796-5530
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 Branch

301-796-5615
Director, Division of Bioresearch Monitoring, WO66, 3446 301-796-5490

Chief, Program Enforcement Branch A

301-796-5654

Chief, Program Enforcement Branch B

301-796-6054

Chief, Special Investigations Branch

301-796-6561
Director, Division of Enforcement A, WO66, 3512 301-796-5770

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 Branch

301-796-5770
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
Director, Office of In Vitro Diagnostic Device Evaluation and Safety, WO66, 5680 301-796-5453

Deputy Director, Patient Safety and Product Quality

301-796-6225

Deputy Director, New Product Evaluation

301-796-5454
Director, Office of Communication, Education and Radiation Programs, WO66 4312 301-796-5716

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)

Director, Office of Compliance (OC), HFS-600 240-402-2359

Deputy Director (OC), HFS-600

240-402-1364
Division of Enforcement, HFS-605 240-402-1750

Recall and Product Reconditioning Team, HFS-605

240-402-1742

Food Adulteration Assessment Branch, HFS-607

240-402-1611

Labeling and Dietary Supplement Compliance Team, HFS-608

240-402-2148
Division of Field Programs and Guidance, HFS-615 240-402-1988

Field Programs Branch

240-402-2774

Compliance Information Branch

240-402-1910
Director, Office of Cosmetics and Colors (OCAC), HFS-100 240-402-1130

Cosmetics Staff, HFS-125

240-402-1124

Division of Color Certification and Technology, HFS-105

240-402-1108
Director, Office of Nutrition, Labeling and Dietary Supplements, HFS-800 vacant

Deputy Director (ONLDS), HFS-800

240-402-1761

Food Labeling and Standards Staff, HFS-820

240-402-2371

Nutrition Programs Staff, HFS-830

240-402-1450

Division of Dietary Supplement Programs, HFS-810

240-402-1850

Infant Formula and Medical Foods Staff, HFS-850

240-402-1459
Director, Office of Food Safety (OFS), HFS-300 240-402-1700

Deputy Director (OFS), HFS-300

vacant

Food Processing Evaluation Team, HFS-302

240-402-1781

Division of Seafood Science and Technology, HFS-400

251-690-3368

Division of Food Processing Science and Technology, HFS-450

708-728-4154

Division of Plant and Dairy Food Safety, HFS-315

240-402-1488

Retail Food & Cooperative Programs Coordination Staff, HFS-320

240-402-2149

Produce Safety Staff, HFS-317

240-402-1636

Division of Seafood Safety, HFS-325

240-402-1422
Director, Office of Regulatory Science (ORS), HFS-700 vacant

Deputy Director (ORS), HFS-700

240-402-1908

Division of Analytical Chemistry, HFS-705

240-402-1898

Division of Microbiology, HFS-710

240-402-2020

Division of Bioanalytical Chemistry, HFS-715

240-402-1786

Center for Veterinary Medicine (CVM)

Director, Office of Surveillance and Compliance (OS &C), HFV-200 240-453-6830
Deputy Director, OS&C, HFV-200 240-453-6830
Director, Division of Surveillance, HFV-210 240-276-9062

Team Leader, Marketed Product Information Team, HFV-212

240-276-9075

Team Leader, Unapproved Hazard and Jurisdictional Review Team, HFV-214

240-276-9063

Team Leader, Post-Approval Review Team, HFV-216

240-453-6802
Director, Division of Animal Feeds, HFV-220 240-453-6864

Team Leader, Feed Safety Team, HFV-222

240-453-6851

Team Leader, Ingredient Safety Team, HFV-224

240-453-6879

Team Leader, Medicated Feeds Team, HFV-226

240-453-6858

Team Leader, Nutrition and Labeling Team, HFV-228

240-453-6866
Director, Division of Compliance, HFV-230 240-276-9200

Team Leader, Complaint/Emergency/Recall Team, HFV-231

240-276-9237

Team Leader, Post-Market Compliance Team, HFV-232

240-276-9204

Team Leader, Drug Residue Compliance Team, HFV-233

240-276-9209

Team Leader, Pre-Market Compliance and Administrative Actions Team, HFV-234

240-276-9238

Team Leader, Programs and Operations Support Team, HFV-235

240-276-9209
Director, Division of Veterinary Product Safety HFV-240 240-453-6844

Team Leader, Adverse Drug Event Review Team, HFV-241

240-276-9068

Team Leader, Adverse Event Review Team, HFV-242

240-276-9056

Team Leader, Data Management and Analysis Team, HFV-243

240-276-9071

Center for Tobacco Products (CTP)

Director, Office of Compliance and Enforcement (OCE) 301-796-9295

Deputy Director

301-796-8569

ORA Liaison, General Inquiries

301-796-9338

Director, Division of Enforcement and Manufacturing

301-796-5533

Director, Division of Promotion, Advertising and Labeling Compliance

301-796-9235

Director, Division of State Programs

301-796-9297

 

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