ORA Field Leadership Contacts
The Office of Regulatory Affairs (ORA) staff are assigned to Program Areas, where they specialize in a commodity. Each Program Area is organized by Divisions, listed on the Division Boundary Maps and Fact Sheets, which are managed by a Program Division Director (PDD). Some PDDs manage the District Office as the District Director (denoted by an asterisk (*) in the chart below). Each Program Division has a Director of Investigations Branch (DIB) as well as a Director of Compliance Branch (DCB). More information about ORA’s organizational structure can be found at Program Alignment and ORA.
Program Areas
- Office of Bioresearch Monitoring Operations (OBIMO)
- Office of Biological Products Operations (OBPO)
- Office of Human and Animal Foods Operations (OHAFO)
- Office of Medical Device and Radiological Health Operations (OMDRHO)
- Office of Pharmaceutical Quality Operations (OPQO)
- Import Operations
- Tobacco Operations
Office of Bioresearch Monitoring Operations
Program Director Name: Chrissy J. Cochran, PhD
Office Telephone: 301-796-5633
Email: [email protected]
| OBIMO | Boundaries | Program Division Director (* denotes District Director) |
Director of Investigations Branch |
|---|---|---|---|
| Division 1 | Alabama, Connecticut, Delaware, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Mississippi, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Vermont, Virgin Islands, Virginia, West Virginia |
Anne E. Johnson, PHI-DO* |
Christine Smith |
| Division 2 | Alaska, American Samoa, Arizona, Arkansas, California, Colorado, Guam, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Mariana Islands, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Mexico, North Dakota, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington, Wisconsin, Wyoming | Eric Pittman Mailing Address: 550 Building 550 West Jackson Blvd, Room 1651 Chicago, IL 60661 Office: 312-596-4259 Email: [email protected] |
Audrey Vigil Mailing Address: Denver Federal Center, Bldg. 20 Room B1526 6th Avenue & Kipling Street Lakewood, CO 80225 Office: 303.231.2721 Email: [email protected] |
Office of Biological Products Operations
Program Director Name: Ginette Y. Michaud, MD
Office Telephone: 240-402-8331
Email: [email protected]
| OBPO | Boundaries | Program Division Director (* denotes District Director) |
Director of Investigations Branch | Director of Compliance Branch |
|---|---|---|---|---|
| Division 1 | Alabama, Connecticut, Delaware, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maine, Maryland, Massachusetts , Mississippi, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Vermont, Virgin Islands, Virginia, West Virginia | Michael Roosevelt Mailing Address: TBA Office: 240-402-1364 Email: [email protected] |
Lisa Harlan Mailing Address: 10 Waterview Blvd. 3rd Floor, Suite 300 Parsippany, NJ Office: 973-331-4914 Email: [email protected] |
Julie Bringger Mailing Address: 400 W. Bay Street, Suite 401 Jacksonville, FL 32202 Office: 904-533-4560 Email: [email protected] |
| Division 2 | Alaska, Arizona, Arkansas, California , Colorado, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Mexico, North Dakota, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington, Wisconsin, Wyoming | Karlton Watson Mailing Address: 1201 Main Street, Suite 7200 Room 7333 Dallas, TX 75202-3908 Office: 214-253-5254 Email: [email protected] |
Tricia Martinez Mailing Address: Airport Center 10100 Reunion Place, Suite 100 San Antonio, TX Office: 210-308-1414 Email: [email protected] |
Catherine Quinlan Mailing Address: 300 River Place, 5th Floor, Room 525 Detroit, MI Office: 313-393-8153 Email: [email protected] |
Office of Human and Animal Food Operations
Program Director Name: Michael C. Rogers, MS
Office Telephone: 240-402-4029
Email: [email protected]
| OHAFO | Boundaries | Program Division Director (* denotes District Director) |
Director of Investigations Branch | Director of Compliance Branch |
|---|---|---|---|---|
| OHAF-East | Vinetta Howard-King (acting) Mailing Address: 10903 New Hampshire Ave WO31 RM3524 Silver Spring, MD Office: 301-796-8254 Email: [email protected] |
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| OHAF-East Division 1 | Connecticut, Maine, Massachusetts , New Hampshire, New York, Rhode Island, Vermont | Ronald Pace* Mailing Address: FDA -158-15 Liberty Avenue, Suite 2029 Jamaica, NY Office: 718-662-5447 Email: [email protected] |
Lori Holmquist Mailing Address: US Custom House 312 Fore Street, Room 108 Portland, ME Office: 781-587-7437 Email: [email protected] |
CDR Catherine Beer, USPHS Mailing Address: I Winners Circle, Rm 110 Albany, NY Office: 518-453-2314 x1015 Email: [email protected] |
| OHAF-East Division 2 | Delaware, District of Columbia, Maryland, New Jersey, Pennsylvania, Virginia, West Virginia | Vacant | Martin Guardia Mailing Address: 6000 Metro Drive Suite 101 Baltimore, MD 21215 Office: 410-779-5430 Email: [email protected] |
Randy Pack Mailing Address: Seton Business Park 6000 Metro Drive Suite 107 Baltimore, MD Office: 410-779-5417 Email: [email protected] |
| OHAF-East Division 3 | Georgia, North Carolina, South Carolina | Ingrid Zambrana* Mailing Address: Annex I - 60 Eighth St NE Room 221 Atlanta, GA Office: 404-253-1284 Email: [email protected] |
Ivy Sweeney Mailing Address: 2077 Convention Centers, Concourse Suite 400 & 485 Suite 400 College Park, GA Office: 404-669-4551 Email: [email protected] |
Derek Price Mailing Address: Annex I - 60 Eighth St NE Room 231 Atlanta, GA Office: 404-253-2277 Email: [email protected] |
| OHAF-East Division 4 | Florida, Puerto Rico, Virgin Islands | Ramon Hernandez Mailing Address: 466 Fernandez Juncos Avenue San Juan, PR Office: 787-729-8588 Email: [email protected] |
Sonia M. Monges Mailing Address: 555 Winderley Place, Suite 200 Maitland, FL 32751 Office: 407-475-4743 Email: [email protected] |
Edwin Ramos Mailing Address: 466 Fernandez Juncos Avenue, Suite 113 San Juan, PR Office: 787-729-8662 Email: [email protected] |
| OHAF-East Division 5 | Alabama, Kentucky, Louisiana, Mississippi, Ohio, Tennessee | Steven Barber* Mailing Address: 6751 Steger Drive, Suite 030 Cincinnati, OH Office: 513-679-2700 x2116 Email: [email protected] |
Thomas Clarida– IB1
|
Toniette Williams Mailing Address: 6751 Steger Drive, St039 Cincinnati, OH Office: 513-679-2700 x2160 Email: [email protected] |
| OHAF-East Division 6 | Illinois, Indiana, Michigan | William Weissinger* Mailing Address: 550 West Jackson Blvd, Room 1651 Chicago, IL Office: 312-596-4200 Email: [email protected] |
Tamara Qtami Mailing Address: 550 West Jackson Blvd, Room 1500 Chicago, IL Office: 312-596-4240 Email: [email protected] |
Kelli Wilkinson Mailing Address: 300 River Place, 5th Floor, Room 501A Detroit, MI Office: 313-393-8120 Email: [email protected] |
| OHAF-West |
Vacant |
|||
| OHAF-West Division 1 | Minnesota, North Dakota, South Dakota, Wisconsin | Michael Dutcher* Mailing Address: 250 Marquette Avenue Minneapolis, MN Office: 612-758-7124 Email: [email protected] |
Gregory Smith Mailing Address: 250 Marquette Avenue, Room 616 Minneapolis, MN Office: 612-758-7155 Email: [email protected] |
Christopher VanTwuyver Mailing Address: 250 Marquette Avenue, Room 684 Minneapolis, MN Office: 612-758-7112 Email: [email protected] |
| OHAF-West Division 2 | Iowa, Kansas, Missouri, Nebraska | LaTonya M. Mitchell* Mailing Address: 8050 Marshall Drive, Room 205 Lenexa, KS Office: 913-495-5108 Email: [email protected] |
Jeffrey Moody Mailing Address: 8050 Marshall Drive, Room 205 Lenexa, KS Office: 913-495-5191 [email protected] |
Miguel Hernandez Sanchez Mailing Address: 8050 Marshall Drive, Room 205 Lenexa, KS Office: 913-495-5101 Email: [email protected] |
| OHAF-West Division 3 | Arkansas, Oklahoma, Texas | Edmundo Garcia* Mailing Address: 1201 Main Street, Suite 7200, Room 6333 Dallas, TX 75202-3908 Office: 214-253-5201 Email: [email protected] |
Karen Daugherty Mailing Address: 1201 Main Street, Suite 7200, Room 6329 Dallas, TX 75202-3908 Office: 214-253-5228 Email: [email protected] |
Jessica Hensley Mailing Address: 8050 Marshall Drive, Suite 205 Lenexa, KS Office: 913-495-5183 Email: [email protected] |
| OHAF-West Division 4 | Arizona, Colorado, New Mexico, Utah Wyoming |
Mark Harris |
Ginger Sykes Mailing Address: RP-SLC RMONR HFR-SW2520 Midland Commerce Center - 2090 N Redwood Rd Salt Lake City, UT 84116 Office: 801-321-5964 x1108 Email: [email protected] |
Jennifer Hicks Mailing Address: DFC Bldg 20 - W. 6th Ave & Kipling St Room B1506B Lakewood, CO Office: 303-236-9723 Email: [email protected] |
| OHAF-West Division 5 | California, Hawaii, Nevada, American Samoa, the Commonwealth of Mariana Islands (CNMI), and Guam | Darla Bracy* Mailing Address: 1431 Harbor Bay Pkwy, Room 214 Alameda, CA Office: 510-337-6773 Email: [email protected] |
Darlene Almogela - IB1
|
Sergio Chavez Mailing Address: 1431 Harbor Bay Pkwy, Room 246 Alameda, CA Office: 510-337-6886 Email: [email protected] |
| OHAF-West Division 6 | Alaska, Idaho, Montana, Oregon, Washington | Miriam Burbach Mailing Address: 22215 26th Ave SE, Suite 210 Bothell, WA Office: 425-302-0400 Email: [email protected] |
Katie Alford Mailing Address: 22215 26th Ave SE, Suite 210 Bothell, WA Office: 425-302-0440 Email: [email protected] |
Lisa Althar Mailing Address: 22215 26th Ave SE, Suite 210 Bothell, WA Office: 425-302-0420 Email: [email protected] |
| OHAF- Division of Domestic HAF Operations |
Gerald Bromley Jr |
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| OHAF-Division of Foreign HAF Operations | Yvette Arline Mailing Address: 12420 Parklawn Drive, Room 2130 Rockville, MD Office: (301) 796-0359 Email: [email protected] |
Miriam Stuckey - IB1
|
||
| OHAF-Office of State Cooperative Programs |
Laurie Farmer, OSCP OD |
Office of Medical Device and Radiological Health Operations
Program Director Name: Jan Welch
Office Telephone: 301-796-5776
Email: [email protected]
| OMDRHO | Boundaries | Program Division Director (* denotes District Director) |
Director of Investigations Branch | Director of Compliance Branch |
|---|---|---|---|---|
| Division 1 | Connecticut, Delaware, District of Columbia, Indiana, Kentucky, Maine, Maryland, Massachusetts , Michigan, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont, Virginia, West Virginia | Joseph Matrisciano* Mailing Address: One Montvale Avenue, Room 4013 Stoneham, MA Office: 781-587-7490 Email: [email protected] |
Arduino Frankovic Mailing Address: FDA -158-15 Liberty Avenue, Suite 4041 Jamaica, NY Office: 718-662-5664 Email: [email protected] |
Gina Brackett Mailing Address: 6751 Steger Drive, St041 Cincinnati, OH Office: 513-679-2700 Email: [email protected] |
| Division 2 | Alabama, Florida, Georgia, Illinois, Iowa, Kansas, Louisiana, Minnesota, Mississippi, Missouri, Nebraska, North Carolina, North Dakota, Puerto Rico, South Carolina, South Dakota, Tennessee, Virgin Islands, Wisconsin | Blake Bevill Mailing Address: 555 Winderley Place, Suite 200 Maitland, FL Office: 407-475-4734 Email: [email protected] |
Kathleen Sinninger Mailing Address: 555 Winderley Place, Suite 200 Maitland, FL Office: 407-475-4715 Email: [email protected] |
Melissa Michurski Mailing Address: 250 Marquette Ave, Suite 600 Minneapolis, MN Office: 612-758-7185 Email: [email protected] |
| Division 3 | Alaska, Arizona, Arkansas, California, Colorado, Hawaii, Idaho, Montana, Nevada, New Mexico, Oklahoma, Oregon, Texas, Utah, Washington, Wyoming | Shari Shambaugh Mailing Address: 1201 Main Street, Suite 7200 Room 6111 Dallas, TX 75202-3908 Office: 214-253-5215 Email: [email protected] |
Eric Anderson Mailing Address: 1431 Harbor Bay Pkwy, Room 227 Alameda, CA Office: 510-337-6752 Email: [email protected] |
Jessica Mu Mailing Address: 19701 Fairchild, RM2153 Irvine, CA Office: 949-608-4477 Email: [email protected] |
Office of Pharmaceutical Quality Operations
Program Director Name: Alonza Cruse
Office Telephone: 240-402-2540
Email: [email protected]
| OPQO | Boundaries | Program Division Director (* denotes District Director) |
Director of Investigations Branch | Director of Compliance Branch |
|---|---|---|---|---|
| Division 1 | Connecticut, Delaware, District of Columbia, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, West Virginia | Diana Amador Toro* Mailing Address: 10 Waterview Blvd. 3rd Floor, Room 300 Parsippany, NJ Office: 973-331-4901 Email: [email protected] |
Karyn Campbell
Nerizza Guerin |
Stephanie Durso Mailing Address: 10 Waterview Blvd. 3rd Floor, Room 300 Parsippany, NJ 07054 Office: 973-331-4911 Email: [email protected] |
| Division 2 | Alabama, Arkansas, Florida, Georgia, Louisiana, Mississippi, North Carolina, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Virgin Islands |
Monica Maxwell
|
Tamala Magee 1201 Main Street, Suite 7200 Room 6129 Dallas, TX 75204-3908 214-253-4904 Office: 310-647-2920 Email: [email protected] |
John Diehl Mailing Address: 1201 Main Street, Suite 7200 Room 6127 Dallas, TX 75204-3908 Office: 214-253-5288 Email: [email protected] |
| Division 3 | Illinois, Indiana, Iowa, Kansas, Kentucky, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, Wisconsin | Art Czabaniuk* Mailing Address: 300 River Place, 5th Floor, Room 417 Detroit, MI Office: 313-393-8154 Email: [email protected] |
Jeffrey Meng Mailing Address: 300 River Place, 5th Floor, Room 547 Detroit, MI Office: 313-393-8272 Email: [email protected] |
Nicholas Lyons Mailing Address: 550 West Jackson Blvd, Room 1624 Chicago, IL Office: 312-596-4220 Email: [email protected] |
| Division 4 | Alaska, Idaho, Montana, Oregon, Washington, Arizona, Hawaii, Nevada, California, Colorado, New Mexico, Utah, Wyoming | Steven Porter* Mailing Address: 19701 Fairchild, RM2181 Irvine, CA Office: 949-608-4448 Email: [email protected] |
Katherine Jacobitz Mailing Address: 4510 Executive Drive, Room 225 San Diego, CA Office: 619-941-3770 Email: [email protected] |
Thomas Berry Mailing Address: DFC Bldg 20 - W. 6th Ave & Kipling St Room I1006 Lakewood, CO Email: [email protected] |
Import Operations
Office of Enforcement and Import Operations
Assistant Commissioner for Import Operations: Dan Solis
Office Telephone: 949-608-3544
Email: [email protected]
Deputy Director for Targeting, Analysis and Support: Faiad Rahaman, Ph.D.
Office Telephone: 301-796-7302
Email: [email protected]
Deputy Director for Import Operations Enforcement, John Verbeten
Office Telephone : 301-796-6677
Email: [email protected]
- For General Import Questions, refer to FDA Import Contacts and Office Locations
- For Specific Import Entry Questions, refer to FDA Import Offices and Ports of Entry
| Imports | Boundaries | Program Division Director (* denotes District Director) |
Director of Investigations Branch | Director of Compliance Branch |
|---|---|---|---|---|
| Division of Southeast Imports | Alaska, Alabama, Arkansas, Florida, Georgia, Indiana (select ports), Kentucky, Louisiana, Mississippi, North Carolina, Puerto Rico, South Carolina, Tennessee and U.S. Virgin Islands | Ruth P. Dixon* Mailing Address: 404 BNA Drive, Building 200, Suite 500 Nashville, TN Office: 615-366-7803 Email: [email protected] |
Giovanna Serpa - IB1 Chris Boulmay - IB2 |
Tammara P. Threats Mailing Address: 959 Ridgeway Loop Rd. Suite 100 Memphis, TN 38120 Office: 901-333-3534 Email: [email protected] |
| Division of Northern Border Imports | Idaho, Illinois, Indiana, Maine, Michigan, Minneapolis, Montana, New Hampshire, North Dakota, New York, Ohio, South Dakota, Vermont, Washington, and Wisconsin | Keith Jasukaitis Mailing Address: 300 River Place, 5th Floor, Room 522 Detroit, MI Office: 313-393-8141 Email: [email protected] |
Dean Rugnetta- East Eric Joneson - West |
Sherea Dillon Mailing Address: 550 West Jackson Blvd, Room 1631 Chicago, IL Office: 312-596-4244 Email: [email protected] |
| Division of West Coast Imports | California, Hawaii, Nevada, Oregon, and Washington. | Dr. Kathleen Turner Mailing Address: One World Trade Center, Suite 300 Long Beach, CA Office: 562-256-9202 |
Gordon Chu Mailing Address: One World Trade Center, Suite 300 Long Beach, CA Office: 562-256-9203 Email: [email protected] |
Lawton Lum Mailing Address: 1431 Harbor Bay Pkwy, Room 250 Alameda, CA Office: 510-337-6792 Email: [email protected] |
| Division of Southwest Imports | Arizona, Colorado, Iowa, Kansas, Missouri, Nebraska, New Mexico, Oklahoma, Texas, Utah, and Wyoming | Todd Cato Mailing Address: 1201 Main Street, Suite 7200 Room 6311 Dallas, TX 75204-3908 Office: 214-253-5284 Email: [email protected] |
Stacy Below Mailing Address: 1201 Main Street, Suite 7200 Room 6313 Dallas, TX 75204-3908 Office: 214-253-5324 Email: [email protected] |
Alex Lopez Mailing Address: 216 West Village Blvd, Suite 107 Laredo, TX Office: 956-721-2431 Email: [email protected] |
| Division of Northeast Imports | Connecticut, District of Columbia, Delaware, Massachusetts, Maryland, Maine, New York, New Hampshire, Pennsylvania, Rhode island, Virginia, Vermont, and West Virginia | CAPT Nazmul Hassan Mailing Address: FDA -158-15 Liberty Avenue, Suite 3037 Jamaica, NY 11433 Office: 718-662-5707 Email: [email protected]
|
Theresa Smedley (Acting) Mailing Address: Belts Business Center, 608-A Folcroft Street Baltimore, MD 21224. Office: 410-631-0322 x118 Email: [email protected] |
Anna Alexander Mailing Address: FDA -158-15 Liberty Avenue, Suite 4046 Jamaica, NY 11433 Office: 718-662-5683 Email: [email protected] |
Tobacco Operations
Contact Name: Vacant
Additional Contact Information
- Office of Regulatory Affairs Executive Advisory Council (EAC) Listing
- ORA District Directors
- Program Alignment and ORA
- ORA Program Division Boundary Maps and Fact Sheets