Skip page top navigationFDA Logo--links to FDA home page Logo of and Link to start page of Office of Regulatory Affairs, U.S. Food and Drug Administration U.S. Food and Drug Administration Office of Regulatory Affairs HHS Logo and link to Department of Health and Human Services website

FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search  Vignette Managed Content: Click here for Metadata

Inspection References
Investigations Operations Manual 2008
Previous Page | Document TOC| Next Page
Updated: 2008-02-08

Contents

ORA Headquarters Offices and Division - Headquarters Offices and Divisions

Field Directory - Regional and District Offices, Laboratories and Resident Posts

Field Monitors - District Office Program Area Specialists and Project Monitors

ORA Laboratory Information - Sample Coordination, Mailing Addresses, and Early Notification of Sample Shipments

IOM Change Request Form


HEADQUARTERS

Associate Commissioner for Regulatory Affairs

Office of Resource Management

Office of Regional Operations

Office of Enforcement

Office of Criminal Investigations


ORA FIELD DIRECTORY
NORTHEAST REGION

New York Regional Office
New England Regional Office
Northeast Regional Lab
Winchester Engineering and Analytical Center
New England District
New York District
CENTRAL REGION

Philadelphia Regional Office
Chicago Regional Office
Forensic Chemistry Center
Philadelphia District
Baltimore District
Cincinnati District
New Jersey District
Chicago District
Detroit District
Minneapolis District
SOUTHEAST REGION

Atlanta Regional Office
Southeast Regional Laboratory
Atlanta District
New Orleans District
Florida District
San Juan District
SOUTHWEST REGION

Dallas Regional Office
Kansas City Regional Office
Arkansas Regional Laboratory
Dallas District
Denver District
Kansas City District
Southwest Import District
PACIFIC REGION

San Francisco Regional Office
Seattle Regional Office
Pacific Regional Laboratory Northwest
Pacific Regional Laboratory Southwest
Los Angeles District
San Francisco District
Seattle District Office
 


ORA HEADQUARTERS

Associate Commissioner for Regulatory Affairs
Office of Resource Management
Office of Regional Operations
Office of Enforcement
Office of Criminal Investigations

Associate Commissioner for Regulatory Affairs, (ACRA), 5600 Fishers Lane, Rockville, MD 20857

Emergency (after hours) Answering Service - Office of Crisis Management (301) 443-1240

Margaret O' K. Glavin, Associate Commissioner for Regulatory Affairs, Rm. 14-90, HFC-1 (301) 827-3101 FAX (301) 443-6591

David J. Horowitz, Deputy Associate Commissioner for Compliance Policy, Rm. 14-90, HFC-1, (301) 827-3101 FAX (301) 443-6591

Michael A. Chappell, Deputy Associate Commissioner for Field Operations, Rm 14C-08, HFC-1, (301) 827-3107 FAX (301) 443-6591

Alyson L. Saben, Special Assistant to the ACRA, Rm. 14-90, HFC-1, (301) 827-3101 FAX (301) 443-6591

Brad Stone, Program Manager, Rm. 13-45, HFC-1, (301) 827-9501 FAX (301) 443-6591

Amy R. Folden, Executive Assistant, Rm. 14-90, HFC-1, (301) 827-3101 FAX (301) 443-6591

Carolyn Becker, Regulatory Counsel to ACRA, Rm. 13-91, HFC-1, (301) 827- 2806 FAX (301) 827-0963

Michele Mital, Policy Analyst, Rm. 13-91, HFC-1, (301) 827-4225 FAX (301) 827-0963

Lori Love, Senior Advisor for Clinical Science, Rm. 5A-55, HFC-1, (301) 827-3684 FAX (301) 443-6591

Jeanne Roman, Director, ORA Executive Operations Staff, Rm. 13-91, HFC-1, (301) 827-0947 FAX (301) 827-0963

Office of Resource Management, (ORM), 5600 Fishers Lane, Rockville, MD 20857

James M. Strachan, Director ORM, Rm. 13-45, HFC-10, (301) 443-2175 FAX (301) 443-7270

Michael Roosevelt, Deputy Director ORM, Rm. 13-45, HFC-10, (301) 827-1638

Vacant, Labor Management Relations Specialist, Rm. 13-45, HFC-10, (301) 827-1643

Richard Garwood, Dir. Div. of Management Operations, Rm. 5A-55 , HFC-20, (301) 827-2864 FAX (301) 827-7267

CDR Diann Shaffer, Commissioned Corps Liaison, HFC-20, Rm. 5A-55, 5600 Fishers Ln., Rockville, MD 20857, (301) 827-1124

Michelle M. Berger, Dir., Management Operations and Analysis Group, Rm. 5A-55, HFC-21, (301) 827-1452

Lee Swerock, Dir., Financial Program & Analysis Group, Rm.5A-55, HFC-21, (301) 827-1206

Randy Higgins, Dir., Facilities Mgmt. Group, Rm. 5A-55, HFC-21, (301) 827-1202

Karen Flanigan, Safety Management Officer, Rm. 5A-55, HFC-21, (301) 827-1212

Ron Ottes, FDA History Office, Rm. 12-69, HFC-24, (301) 827-3758

John Swann, FDA History Office, Rm. 12-69, HFC-24, (301) 827-3756 FAX (301) 443-7270

Suzanne White Junod, FDA History Office, Rm. 12-69, HFC-24, (301) 827-3759 FAX (301) 443-7270

Mark Gregory, Director, Office of Information Technology - ORA, Rm. 5A-05, HFC-30, (301) 827-4090 

FAX (301) 443-7270

Donald Chi, Associate Director, Office of Information Technology - ORA, Rm. 5A-05, HFC-30, (301) 827-1562 FAX (301) 443-0868

John A. Lechus, Dir., Div. of Planning, Evaluation & Management, Rm. 12-38, HFC-40, (301) 827-1637 FAX (301) 443-7212

Vacant, Dir., Prog. Planning & Workforce Management Br., Rm. 12-38 HFC-41

Lynnette I. Riggio, Dir. Program Evaluation Br., Rm. 12-38, HFC-42, (301) 827-1626

Gary German, Dir., Div. of Human Resource Development, HFC-60, (301) 594-1710 FAX (301) 594-1966

Vacant, Dep. Dir., Div. of Human Resource Development, HFC-60, (301) 594-2174 FAX (301) 594-1966

 

Office of Regional Operations, (ORO), 5600 Fishers Lane, Rockville, MD 20857

Emergency (after hours) Answering Service (301) 443-1240

Deborah D. Ralston, Dir. ORO, Rm. 13-61, HFC-100, (301) 443-6230 FAX (301) 443-1778

Steven M. Solomon, DVM, MPH, Dep. Dir. ORO, Rm. 13-61, HFC-101, (301) 443-6230

Kara Lynch, Special Assistant to the Dir., Rm. 13-61, HFC-102, (301) 443-6230

Britt L. Pratt, International Affairs Program Manager, Rm. 13-82, HFC-101, (301) 827-5646 FAX (301) 443-3757

Michael C. Rogers, Dir. Div. of Field Investigations, Rm. 13-64, HFC-130, (301) 827-5653 FAX (301) 443-3757

Patricia L. Alcock, Dep. Dir. Div. of Field Investigations, Rm. 13-64, HFC-130, (301) 827- 5653 FAX (301) 443-3757

Gerald W. Miller, Dir., Domestic Operations Branch, Rm. 13-64, HFC-130, (301) 827-5653 FAX (301) 443-3757

Rebecca Ramos Hackett, Manager, Internat'l Oper. Br., Rm. 13-71, HFC-130, (301) 827-3777 FAX (301) 827-6685

Carl Sciacchitano, Dir. Div. of Field Science, Rm. 12-41, HFC-140, (301) 827-1232 FAX (301) 827-4575

Thomas Savage, Dep. Dir. Field Science, Rm. 12-41, HFC-140, (301) 443-3320

Richard H. Barnes, Dir. Div. of Fed-State Rel, Rm. 12-07, HFC-150, (301) 827-6906 FAX (301) 443-2143

Vacant, Staff Manager, Contracts & Grants Staff, Rm. 12-07, HFC-150, (301) 827-2906

Catherine McDermott, Staff Manager, Public Affairs & Information Staff, Rm. 12-07 HFC-150, (301) 827-2910

Domenic J. Veneziano, Dir. Div. of Import Oper & Policy, HFC-170, (301) 443-6553 FAX (301) 594-0413

DIOP: Overnight/Express Mail to:5600 Fishers Lane, Room 12-38, Rockville, MD 20857

Vacant, Deputy Dir. Div. of Import Operations and Policy, HFC-170, (301) 594-1218 FAX (301) 594-3787

Steven G. Kendall, Dir., Systems Branch, HFC-171, (301) 443-6553

John E. Verbeten, Dir., Operations and Policy Branch, HFC-172, (301) 594-3853

Laura J. Draski, Dir., Prior Notice Center, HFC-180, (703) 621-7809

Anthony C. Taube, Dep. Dir., Prior Notice Center, HFC-180, (866) 521-2297

 

Office of Enforcement, (OE), 15800 Crabbs Branch Way, Rockville, Md. 20855

(Regular Mail to: 5600 Fishers Lane, Rockville, MD 20857 )

David Elder, Director OE, HFC-200, (240) 632-6800 FAX (240) 632-6810

Vacant, Director of Compliance, OE, HFC-200, (240) 632-6800 FAX (240) 632-6810

Donald Vasbinder, Special Assistant OE, HFC-200, (240) 632-6804 FAX (240) 632-6810

Gary Coody, National Health Fraud Coordinator, OE, HFC-200, (240) 632-6806 FAX (240) 632-6810

Fred Richman, Dir. Div. of Compl Mgmt & Oper, HFC-210, (240) 632-6850 FAX (240) 632-6859

Vacant, Dir. Div. of Compl Policy, HFC-230, (240) 632-6852 FAX (240) 632-6861

David J. Gallant, Dir. Div. Compl Info & QA, HFC-240, (240) 632-6812 FAX (240) 632-6824

 

Office of Criminal Investigations, (OCI), HFC-300, 7500 Standish Place Suite 250 N., Rockville, MD 20855

Terrell L. Vermillion, Director, (240) 276-9500, FAX (240) 276-8368

Horace Coleman, Special Agent in Charge (SAIC), Investigative Operations Division, (240) 276-9500, FAX (240) 276-8368

Loretta Stipa, Special Agent in Charge, Administrative Operations Division, (240) 276-9500, FAX (240) 276-8387

OCI, Chicago Field Office, HFH-530, 901 Warrenville Road, Suite 360, Lisle, IL 60532

Michael Cleary, Special Agent in Charge, (630) 769-5520, FAX (630) 769-5550 (Covers IL, IN, MI, MN, ND, SD, WI)

OCI, Detroit Domicile

Michael Pearl, Special Agent, (248) 960-3138, FAX (248) 960-3146

OCI, Minneapolis Domiciles

Kenneth Kulick, Special Agent, (651) 433-5404, FAX (651) 433-4110

Sherry Zwart, Special Agent, (715) 262-9820, FAX (715) 262-9844

OCI, Kansas City Field Office, HFH-510, 5799 Broadmoor Street, Suite 600, Mission, KS 66202

Larry Sperl, Special Agent in Charge, (913) 384-7400, FAX (913) 384-7421 (Covers AR, CO, IA, KS, MO, NE, NM, OK, TX, UT, WY)

OCI, Austin Resident Office, HFH-511, 9430 Research Blvd., Bldg 2, Ste 250, Echelon II, Austin, TX 78759

James Cook, Resident Agent In Charge, (512) 349-2599, FAX (512) 349-2986

OCI, Dallas Domicile

Larry Enmon, Special Agent, (972) 559-5134, FAX (972) 559-5606

Tommy Hennesy, Special Agent, (940) 464-4601, FAX (940) 464-4601

Wade Moon, Special Agent, (469) 628-6267, FAX (512) 349-2986

OCI, Denver Domiciles

Mary LaFrance, Special Agent, (303) 471-1106, FAX (303) 471-6456

Russell Herman, Special Agent, (303) 674-1006, FAX (303) 674-1042

OCI, Houston Domicile

Douglas Mason, Special Agent, (713) 661-7164, FAX (713) 661-7164

James Miller, Special Agent, (936) 321-2230, FAX (936) 321-2230

Michael Pitts, Special Agent, (281) 360-4656, FAX (281) 360-4656

OCI, Omaha Domicile

Douglas Czepa, Special Agent, (402) 597-5721

OCI, San Antonio Domicile

Esteban Morales, Special Agent, (210) 481-6111, FAX (210) 481-6111

OCI, Los Angeles Field Office, HFH-520, Fairway Professional Bldg., 201 Avenida Fabricante, Suite 200, San Clemente, CA 92672

Dan Henson, Special Agent in Charge, (949) 366-4600, FAX (949) 366-4627 (Covers AK, AZ, CA, HI, ID, MT, NV, OR, WA)

OCI, San Francisco Resident Office, HFH-521, 555 12th Street, Suite 275, Oakland, CA 94607

Amy Scott, Resident Agent in Charge, (510) 637-3480, FAX (510) 637-3483

OCI, Boise Domicile

Robert Blenkinsop, Special Agent, (208) 344-7843, FAX (208) 433-3500

OCI, Seattle Domiciles

DaLi Borden, Special Agent, (206) 262-2245, FAX (206) 262-2149

Jimmy Burkhardt, Special Agent, (425) 337-8204, FAX (425) 337-8204

Kenneth Petroff, (425) 227-7079, FAX (425) 227-7079

OCI, Phoenix Domicile

Garrett Chinn, Special Agent, (602) 234-8083, x101, FAX (602) 297-8897

Matthew Sautner, Special Agent, (602) 234-8083 x103, FAX (602) 297-8897

OCI, Metropolitan Washington Field Office, HFH-550, 11750 Beltsville Dr, Suite 200, Beltsville, MD 20705

Kim Rice, Special Agent in Charge, (240) 276-9400, FAX (301) 344-3465

(Covers DE, KY, MD, South NJ, OH, PA, VA, WV, Washington, DC)

OCI, Task Force Maryland, HFH-551, 11750 Beltsville Dr, Suite 200, Beltsville, MD 20705

Kathleen Martin-Weis, Deputy Special Agent in Charge, (240) 276-9400, FAX (301) 344-3464

OCI Cincinnati Domicile

Mark Bartley, Special Agent, (606) 433-0201, FAX (606) 433-0201

Kevin Bereda, Special Agent, (937) 429-5174, FAX (937) 4295174

OCI Philadelphia Domicile

Glen McElravy, Special Agent, (610) 521-7623, FAX (610) 521-4916

Robert Pursel, Special Agent, (610) 521-7624, FAX (610) 521-4916

Michael Widenhouse, Special Agent, (610) 521-2073, FAX (610) 521-4916

OCI, Norfolk Domicile

Timothy Royster, Special Agent, (757) 441-6533 x228, FAX (757) 441-3697

OCI, Miami Field Office, HFH-500, 865 SW 78th Ave., Suite 201, Plantation, FL 33324

David Bourne, Special Agent in Charge, (954) 476-5400, FAX (954) 476-5435 (Covers AL, FL, GA, LA, MS, NC, PR, SC, TN, VI)

OCI, Atlanta Resident Office, HFH-502, 401 W. Peachtree Street, Suite 1917, Atlanta, GA 30308

Robert Hiser, Resident Agent In Charge, (404) 253-2317, FAX (404) 253-2324

OCI, New Orleans Resident Office, HFH-503, 103 Northpark Blvd., Suite 210, Covington, LA 70433

Michael Niemiec, Resident Agent In Charge, (985) 871-5152, FAX (985) 871-6922

OCI, San Juan Resident Office, HFH-501, 525 FD Roosevelt Ave., Suite 1118, San Juan, PR 00918

Ralph Culkin, Resident Agent In Charge, (787) 281-4863, FAX (787) 281-4865 (Covers PR, VI)

OCI Birmingham Domicile

Martha Hughes, Special Agent, (205) 966-6074, FAX (205) 982-2759

Robert Kuykendall, Special Agent, (205) 408-1610, FAX (205) 408-1610

OCI, Nashville Domicile

Bob West, Special Agent, (615) 790-0715, FAX (615) 790-9219

OCI Raleigh Domicile

Paul Pierce, Special Agent, (919) 390-4848

OCI, New York Field Office, HFH-540, 10 Exchange Place, Suite 804, Jersey City, NJ 07302

George Hemmer, Special Agent in Charge, (201) 547-3851, FAX (201) 547-6309 (Covers CT, MA, ME, NH, North NJ, NY, RI, VT)

OCI, Boston Resident Office, HFH-541, 3 Centennial Drive, 2nd Floor, Peabody, MA 01960

Mark Dragonetti, Resident Agent In Charge, (978) 531-5850, FAX (978) 531-7356

OCI, Buffalo Domicile

James Husted, Special Agent, (716) 843-5825, FAX (716) 855-3341

Patrick Rinow, Special Agent, (716) 843-5789, FAX (716) 855-3341

OCI Syracuse Domicile

Joseph Niedzwecki, Special Agent, (315) 635-8183, FAX (315) 635-8183

Sample Coordination, ORA Laboratory Mailing Addresses, and Early Notification of Sample Shipments

Send an e-mail to the receiving laboratory when you ship high priority or many samples (e.g. Market Basket Survey samples). These e-mail addresses are found in the Outlook Global Address List.

See IOM 4.5.5.3 - Samples to Administration Laboratories

Northeast Region

U.S. Food & Drug Administration

Northeast Regional Laboratory (NRL)

158-15 Liberty Ave.

Jamaica, NY 11433-1034

Attn: Sample Custodian

(718) 662-5450 FAX (718) 662-5439

E-mail: ORA NRL Sample Coordination

U.S. Food & Drug Administration

Winchester Engineering & Analytical Center (WEAC)

109 Holton St.

Winchester, MA 01890

Attn: Sample Custodian

(781) 729-5700 x749, FAX (781) 729-3593

E-mail: ORA WEAC Management Team

Southeast Region

U.S. Food & Drug Administration

Southeast Regional Lab (SRL)

60 Eight St. NE

Atlanta, GA 30309

Attn: Sample Custodian

(404) 253-1176 FAX (404) 253-1208

E-mail: ORA SE RL Coordination Team

U.S. Food & Drug Administration

San Juan District Laboratory

466 Fernandez Juncos Ave.

San Juan, PR 00901-3223

Attn: Sample Custodian

(787) 474-9525 FAX (787) 729-6884

E-mail: ORA SE SJN LAB Sample Coordination

Central Region

U.S. Food & Drug Administration

Detroit District Laboratory

300 River Place, Suite 5900

Detroit, MI 48207

Attn: Sample Custodian

(313) 393-8203 FAX (313) 393-8232

E-mail: ORA DET LAB Branch

U.S. Food & Drug Administration

Forensic Chemistry Center (FCC)

6751 Steger Drive

Cincinnati, OH 45237

Attn: Sample Custodian

(513) 679-2700 x180 FAX (513) 679-2761

E-mail: ORA FCC Directors or ORA FCC Team Leaders

U.S. Food & Drug Administration

Philadelphia District Laboratory

900 US Customhouse

200 Chestnut St.

Philadelphia, PA 19106

Attn: Sample Custodian

(215) 717- 3047 Fax (215) 597-5728

E-mail: ORA PHI LABORATORY SUPERVISORS

Southwest Region

U.S. Food & Drug Administration

Arkansas Regional Laboratory (ARL)

3900 NCTR Rd., Bldg. 26

Jefferson, AR 72079-9502

Attn: Sample Custodian

(870) 543-4099 FAX (870) 543-4002

E-mail: ORA ARL Chemistry Team & ORA ARL Micro Supervisors

U.S. Food & Drug Administration

Kansas City District Laboratory

11510 West 80th St.

Lenexa, KS 66214-3338

Attn: Sample Custodian

E-mail: ORA KAN Supervisors

U.S. Food & Drug Administration

Denver District Laboratory

6th & Kipling St, Building 20

Denver Federal Center

Denver, CO 80225-0087

Attn: Sample Custodian

(303) 236-3060 FAX (303) 236-9675

E-mail: ORA DEN LAB Supervisors

Pacific Region

U.S. Food & Drug Administration

Pacific Regional Laboratory Northwest (PRL-NW)

22201 23rd Drive SE

Bothell, WA 98021-4421

Attn: Sample Custodian

(425) 486-8788 FAX (425) 483-4996

E-mail: ORA PAR Lab NW Sample Coordination

U.S. Food & Drug Administration

Pacific Regional Laboratory Southwest (PRL-SW)

19701 Fairchild

Irvine, CA 92612

Attn: Sample Custodian

(949) 608-2907 FAX (949) 608-3567

E-mail: ORA PAR Lab SW Supervisors

U.S. Food & Drug Administration

San Francisco District Laboratory (SAN-DO)

1431 Harbor Bay Parkway

Alameda, CA 94502-7070

Attn: Sample Custodian

(510) 337-6898 FAX (510) 337-6704/5

E-mail: ORA SAN Lab Management

 

Page Top Previous Page | Document TOC | Next Page