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Inspection References
Investigations Operations Manual 2004
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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

Change Request Form (see appendix H) - To request changes/corrections


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
New York City Office
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 DIRECTORY

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

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

John M. Taylor III, Associate Commissioner for Regulatory Affairs, Rm. 14-90, HFC-1 (301) 827-3101 FAX (301) 443-6591

Begin Changed Text(Carolyn Becker and Ann Kirchner,End Changed Text Regulatory Counsels to ACRA, HFC-1, (301) 827-2806 FAX (301) 827-0963

John Marzilli, Deputy Associate Commissioner, Rm. 14-90, HFC-2, (301) 827-3101 FAX 301-443-6591

Steven M. Niedelman, Assistant Commissioner for Regulatory Affairs, HFC-1, (301) 827-3101 FAX (301) 443-6591

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

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

Begin Changed Text(vacant)End Changed Text  Senior Advisor for Regulatory Policy, Rm. 14-90, HFC-2, (301) 827-2682

Lori Love, Senior Advisor for Clinical Science, Rm. 12-A46 HFC-2, (301) 827-3684 FAX (301) 443-6591

Marie Urban, Director, Performance Results Staff, Rm. 13-93, HFC-2, (301) 827-0947 FAX (301) 827-0963

Mary Davis, Equal Opportunity Staff, Rm. 12A-05, HFC-15, (301) 827-2883 FAX (301) 480-7803

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

Begin Changed TextVacant,End Changed Text Director ORM, Rm. 13-45, HFC-10, (301) 443-2175 FAX (301) 443-7270

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

CAPT Virginia Mahady, Commissioned Corps Liaison, HFC-10, HFC-10, Rm. 163, 109 Holton St., Winchester, MA 01890, (781) 729-5700 Ext. 702

Begin Changed TextVacantEnd Changed Text, Labor Management Relations Specialist, Rm. 13-45, HFC-10, (301) 827-1643

Begin Changed TextRichard GarwoodEnd Changed Text, Dir. Div. of Management Operations, Rm.Begin Changed Text 5A-55End Changed Text, HFC-20, Begin Changed Text(301) 443-5821 End Changed Text

Lee Swerock, Dir., Financial Program & Analysis Group, Rm. Begin Changed Text5A-55,End Changed Text HFC-21, (301) 827-1206

Randy Higgins, Dir., Facilities Mgmt. Group, Rm. Begin Changed Text5A-55End Changed Text, HFC-21, (301) 827-1202

Karen Flanigan, Safety Management Officer, Rm. Begin Changed Text5A-55End Changed Text, HFC-21, (301) 827-1212

Ron Ottes, FDA History Office, Rm. Begin Changed Text12-69End Changed Text, HFC-24, (301) 827-3758

John Swann, FDA History Office, Rm. Begin Changed Text12-69End Changed Text, HFC-24, (301) 827-3756 FAX (301) 443-7270

Suzanne White Junod, FDA History Office, Rm. Begin Changed Text12-69,End Changed Text HFC-24, (301) 827-3759 FAX (301) 443-7270

Mark Gregory, Director, Office of Information Technology, Rm. Begin Changed Text5A-05End Changed Text, HFC-30, (301) 827-4090 FAX (301) 443-7270

Donald Chi, Associate Director, Office of Information Technology, Rm. Begin Changed Text5A-05,End Changed Text HFC-30, (301) 827-1562 FAX (301) 443-0868

Carol Stone, Director, Infrastructure Applications Branch,Begin Changed Text Rm. 12-77,End Changed Text HFC-33, (301) 827-1561

Begin Changed TextMarvin Bell, Dir. Enterprise Systems Br., Rm. 5A-08, HFC-4, (301) 827-5504End Changed Text

Begin Changed TextLaurie Hager, Dir. Customer Support Branch, Rm 5A-05, HFC-31 (301) 827-2683End Changed Text

Begin Changed TextDavid Graves, ORA IT Enterprise Architect, Twinbrook 5, HFC-30 (301) 827-2887End Changed Text

Susan C. Baer, Dir. Planning, Evaluation & Management Div., Rm. 12-38, HFC-40, (301) 827-1626 FAX (301) 443-7212

Vacant, Deputy Dir. Planning, Evaluation and Management Br., Rm. 12-38, HFC-41, (301) 827-1629

Begin Changed TextMichael RooseveltEnd Changed Text, Dir. Prog. Planning & Workforce Management Br., Rm. 12-38 HFC-41, (301) 827-1638

John A. Lechus, Dir. Program Evaluation Br., Rm. 12-38, HFC-42, (301) 827-1637

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

Leona O'Reilly, Dep. Dir. Div. of Human Resource Development, HFC-60, (301) 594-2174 FAX (301) 594-1966

Begin Changed TextVacantEnd Changed Text, Dir., Div. Of Personnel Operations, HFC-50, Rm. 7B-24, (301) 827-4074

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, 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

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

Patricia Alcock Lefler, 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

Michael Olson, 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, Div. of Fed-State Rel, Rm. 12-07, HFC-150, (301) 827-2905 FAX (301) 443-2143

Paul Raynes, Dep. Dir. Div. of Fed-State Rel., Rm. 12-07 HFC-150, (301) 827-2910

Cynthia Leggett, Pub Affairs & Health Fraud, Rm. 12-17, HFC-110, (301) 827-2914 FAX (301) 443-2143

Carl R. Nielsen, Dir. Div. of Import Oper & Policy, HFC-170, (301) 443-6553 FAX (301) 594-0413

(Begin Changed TextOvernight/Express Mail to: 5600 Fishers Lane, Room 12-38, Rockville, MD 20857)End Changed Text

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

Vacant, Dir., Systems Branch, HFC-171, (301) 443-6553

Office of Enforcement, (OE), 1350 Piccard Dr., 4th Floor, Rockville, Md. 20850

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

Begin Changed TextDavid ElderEnd Changed Text, Director OE, HFC-200, (301) 827-0421 FAX (301) 827-1222

Begin Changed TextCarl Draper,End Changed Text Deputy Director OE, HFC-201, (301) 594-4611 FAX (301) 594-4638

Donald Vasbinder, Special Assistant OE, HFC-201, (301) 827-0414 FAX (301) 827-1222

Sandra Whetstone, Dir. Div. of Compl Mgmt & Oper, HFC-210, (301) 827-0391 FAX (301) 827-0342

Lana Ogram, Dir. Div. of Compl Policy, HFC-230, (301) 827-0393 FAX (301) 827-0482

Scott MacIntire, Dir. Div. Comp Info & QA, HFC-240, (301) 827-0386 FAX (301) 827-0482

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

Terrell L. Vermillion, Director, (301) 294-4030 FAX (301) 594-1971

James Dahl, Assistant Director, Special Programs, (301) 294-4030 FAX (301) 594-1971

Rodney V. Turner, Begin Changed TextAssistant Director for InvestigationsEnd Changed Text, (301) 294-4030 FAX (301) 594-1971

Kathleen Martin-Weis, Special Agent in Charge (SAIC), Begin Changed TextInvestigative Operations DivisionEnd Changed Text, (301) 294-4030 Begin Changed TextFAX (301) 594-1971End Changed Text

Begin Changed TextThomas Doyle, SAIC, Administrative Operations Division, (301) 294-4030 FAX (301) 827-1234End Changed Text

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

Michael Cleary, SAIC, (630) 769-5520 FAX (630) 769-5550 (Covers IL, IN, MI, MN, ND, SD, WI)

OCI, Minneapolis Domicile, Begin Changed TextP.O. Box 308End Changed Text, Forest Lake, MN 55025

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

OCI, Kansas City Field Office, HFH-510, Begin Changed Text5799 Broadmoor Street, Suite 600, Mission, KS 66202 End Changed Text

Larry Sperl, SAIC, Begin Changed Text(913) 384-7400End Changed Text FAX (913) 384-7421 Covers AR, CO, IA, KS, MO, NE, NM, UT, WY)

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

James Cook, Assistant Special Agent in Charge (ASAIC), (512) 349-2599 FAX (512) 349-2986 Covers OK, TX)

OCI, Dallas Domicile, P.O. Box 270760, Flower Mound, TX Begin Changed Text75027End Changed Text

Begin Changed TextLarry Enmon, Special Agent (SA), (972) 559-5134 FAX (972) 559-5608End Changed Text

Tommy Hennesy, SA, (214) 513-2779 FAX (214) 513-2779

OCI, Denver Domicile - Begin Changed TextvacantEnd Changed Text

OCI, Houston Domicile, P.O. Box 273406, Houston, TX 77277-3406

Douglas Mason, SA (713) 661-7164 FAX (713) 661-7164

Begin Changed TextJames Miller, SA (936) 321-2230 FAX (936) 321-2230End Changed Text

Begin Changed TextMichael Pitts, SA (281) 360-4656 FAX (281) 360-4656End Changed Text

OCI, San Antonio Domicile, Begin Changed TextP.O. Box 701223, San Antonio, TX 78270End Changed Text

Esteban Morales, SA, Begin Changed Text(210) 481-6111 FAXEnd Changed TextBegin Changed Text (210) 481-6111End Changed Text

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

Begin Changed TextDan HensonEnd Changed Text, SAIC, (949) 366-4600 FAX (949) 366-4627End Changed Text (Covers Begin Changed TextAZ, So.CAEnd Changed Text)

OCI, San Francisco Resident Office, HFH-521, Begin Changed TextOakland Federal Bldg.,End Changed Text 1301 Clay St., Rm. 260 South, Oakland, CA 94612-5201

Begin Changed TextAmy MuraskiEnd Changed Text, Begin Changed TextResident Agent in Charge (RAIC)End Changed Text, (510) 637-3480 FAX (510) 637-3483 (Covers AK, No. CA, HI, ID, MT, NV, OR, WA)

OCI, Seattle Domicile, 22833 Bothell-EVT HWY, #1285, Bothell, WA 98021-9365

DaLi Borden, SA, (206) 262-2245 FAX (206) Begin Changed Text262-2245End Changed Text

Begin Changed TextRubin Romero, SA, (360) 332-5771 ext. 3104 FAX (360) 756-0064End Changed Text

OCI, Phoenix Domicile, Begin Changed Text3010 North 2nd Street, Suite 110, Phoenix, AZ 85012End Changed Text

Begin Changed TextGarrett Chinn, SA, (602) 234-8083, x101 FAX (602) 297-8897End Changed Text

Robert Olexy, SA (Begin Changed Text602) 234-8083 x102 FAX (602) 297-8897End Changed Text

OCI, Metropolitan Washington Field Office, HFH-550, 4041 Powder Mill Rd, Suite 200, Calverton, MD 20705

Kim Rice, SAIC, (301) 902-1500 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, 1st Floor, Suite 100, Beltsville, MD 20705

Charles Zielinski, ASAIC, (301) 344-0614 FAX (301) 344-0002

OCI Philadelphia Domicile, P.O. 39845, Philadelphia, PA 19106-9845

Begin Changed TextMarc Hess, SA, (215) 861-8253 FAX (215) 861-8593End Changed Text

Glen McElravy, SA (215) 861-8315 FAX (215) 861-8593

OCI, Norfolk Domicile, Begin Changed Text200 Granby St., Suite 600, Norfolk, VA 23510End Changed Text

Timothy Royster, SA Begin Changed Text(757) 441-6533 x204 FAX (757) 441-3697End Changed Text

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

David Bourne, SAIC, (954) 476-5400 FAX (954) 476-5435 (Covers AL, FL, LA, MS,Begin Changed Text NC, SCEnd Changed Text, TN)

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

Leroy Wagner, RAIC, (404) 253-2317 FAX (404) 253-2324 (Covers GA)

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

Michael Niemiec, RAIC, (985) 871-5152 FAX (985) 871-6922 Begin Changed Text(Covers LA, AL, MS,TN)End Changed Text

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

Begin Changed TextRalph Culkin, ActingEnd Changed Text RAIC, (787) 281-4863 FAX (787) 281-4865 (Covers PR, VI)

OCI Tampa Domicile, 2203 Lois Avenue, Suite 600, Tampa, FL 33607

Randy Matteson, SA, (813) 348-1900 Begin Changed Textx2063End Changed Text FAX (813) 348-1871

OCI, Nashville Domicile, 330 Franklin Rd, Suite 135-A-108, Brentwood, TN 37027

Begin Changed TextLarry Loftis,End Changed Text SA, (615) 377-7782 FAX Begin Changed Text(615) 377-8541 End Changed Text

Begin Changed TextBob West, SA, (615) 790-0715 FAX (615) 790-9219End Changed Text

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

George (Stu) Magee, SAIC, (201) 547-3851 FAX (201) 547-6309 (Covers CT, ME, NH, North NJ, NY, RI, VT)

OCI, Boston Resident Office, HFH-541 3 Centennial Drive, 2nd Floor, Peabody, MA 09160

Mark Dragonetti, RAIC, (508) 531-5850 FAX (508) 531-7356 (Covers MA)

OCI, Buffalo Domicile, 138 Delaware Ave., Rm. 563, Buffalo, NY 14202

James Husted, SA, (716) 551-4811 Begin Changed TextxEnd Changed Text825 FAX (716) 855-3341

Begin Changed TextPatrick Rinow, SA, (716) 843-5700 x589 FAX (716) 855-3341End Changed Text

Begin Changed TextOCI Syracuse Domicile, P.O. Box 424, Baldwinsville, NY 13027End Changed Text

Begin Changed TextJoseph Niedzwecki, SA, (315) 635-8183 FAX (315) 635-8183End Changed Text
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