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: Chrissy.Cochran@fda.hhs.gov
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: Eric.Pittman@fda.hhs.gov |
Audrey Vigil Mailing Address: Denver Federal Center, Bldg. 20 Room B1526 6th Avenue & Kipling Street Lakewood, CO 80225 Office: 303.231.2721 Email: Audrey.Vigil@fda.hhs.gov |
Office of Biological Products Operations
Program Director Name: Ginette Y. Michaud, MD
Office Telephone: 240-402-8331
Email: Ginette.Michaud@fda.hhs.gov
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 | Elizabeth Waltrip Mailing Address: 555 Winderley Place Suite 200 Maitland, FL Office: 407-475-4740 Email: Elizabeth.Waltrip@fda.hhs.gov |
Lisa Harlan Mailing Address: 10 Waterview Blvd. 3rd Floor, Suite 300 Parsippany, NJ Office: 973-331-4914 Email: Lisa.Harlan@fda.hhs.gov |
Julie Bringger Mailing Address: 400 W. Bay Street, Suite 401 Jacksonville, FL 32202 Office: 904-533-4560 Email: Julie.Bringger@fda.hhs.gov |
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: 4040 N Central Expressway Room 434 Dallas, TX Office: 214-253-5254 Email: Karlton.Watson@fda.hhs.gov |
Tricia Martinez Mailing Address: Airport Center 10100 Reunion Place, Suite 100 San Antonio, TX Office: 210-308-1414 Email: Tricia.Martinez@fda.hhs.gov |
Catherine Quinlan Mailing Address: 300 River Place, 5th Floor, Room 525 Detroit, MI Office: 313-393-8153 Email: Catherine.Quinlan@fda.hhs.gov |
Office of Human and Animal Food Operations
Program Director Name: Michael C. Rogers, MS
Office Telephone: 240-402-4029
Email: Michael.Rogers@fda.hhs.gov
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: Vinetta.HowardKing@fda.hhs.gov |
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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: Ronald.Pace@fda.hhs.gov |
Lori Holmquist Mailing Address: US Custom House 312 Fore Street, Room 108 Portland, ME Office: 781-587-7437 Email: Lori.Holmquist@fda.hhs.gov |
CDR Catherine Beer, USPHS Mailing Address: I Winners Circle, Rm 110 Albany, NY Office: 518-453-2314 x1015 Email: Catherine.Beer@fda.hhs.gov |
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: Martin.Guardia@fda.hhs.gov |
Randy Pack Mailing Address: Seton Business Park 6000 Metro Drive Suite 107 Baltimore, MD Office: 410-779-5417 Email: Randy.Pack@fda.hhs.gov |
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: Ingrid.Zambrana@fda.hhs.gov |
Ivy Sweeney Mailing Address: 2077 Convention Centers, Concourse Suite 400 & 485 Suite 400 College Park, GA Office: 404-669-4551 Email: Ivy.Sweeney@fda.hhs.gov |
Derek Price Mailing Address: Annex I - 60 Eighth St NE Room 231 Atlanta, GA Office: 404-253-2277 Email: Derek.Price@fda.hhs.gov |
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: Ramon.Hernandez@fda.hhs.gov |
Sonia M. Monges Mailing Address: 555 Winderley Place, Suite 200 Maitland, FL 32751 Office: 407-475-4743 Email: Sonia.Monges@fda.hhs.gov |
Edwin Ramos Mailing Address: 466 Fernandez Juncos Avenue, Suite 113 San Juan, PR Office: 787-729-8662 Email: Edwin.Ramos@fda.hhs.gov |
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: Steven.Barber@fda.hhs.gov |
Thomas Clarida– IB1
|
Toniette Williams Mailing Address: 6751 Steger Drive, St039 Cincinnati, OH Office: 513-679-2700 x2160 Email: Toniette.Williams@fda.hhs.gov |
OHAF-East Division 6 | Illinois, Indiana, Michigan | William Weissinger* Mailing Address: 550 West Jackson Blvd, Room 1651 Chicago, IL Office: 312-596-4200 Email: William.Weissinger@fda.hhs.gov |
Tamara Qtami Mailing Address: 550 West Jackson Blvd, Room 1500 Chicago, IL Office: 312-596-4240 Email: Tamara.Qtami@fda.hhs.gov |
Kelli Wilkinson Mailing Address: 300 River Place, 5th Floor, Room 501A Detroit, MI Office: 313-393-8120 Email: Kelli.Wilkinson@fda.hhs.gov |
OHAF-West |
Vacant
|
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OHAF-West Division 1 | Minnesota, North Dakota, South Dakota, Wisconsin | Michael Dutcher* Mailing Address: 250 Marquette Avenue Minneapolis, MN Office: 612-758-7124 Email: Michael.Dutcher@fda.hhs.gov |
Gregory Smith Mailing Address: 250 Marquette Avenue, Room 616 Minneapolis, MN Office: 612-758-7155 Email: Greg.Smith@fda.hhs.gov |
Christopher VanTwuyver Mailing Address: 250 Marquette Avenue, Room 684 Minneapolis, MN Office: 612-758-7112 Email: Chris.vanTwuyver@fda.hhs.gov |
OHAF-West Division 2 | Iowa, Kansas, Missouri, Nebraska | Cheryl Bigham* Mailing Address: 8050 Marshall Drive, Room 205 Lenexa, KS Office: 913-495-5108 Email: Cheryl.Bigham@fda.hhs.gov |
Jeffrey Moody Mailing Address: 8050 Marshall Drive, Room 205 Lenexa, KS Office: 913-495-5191 Jeffrey.Moody@fda.hhs.gov |
Miguel Hernandez Sanchez Mailing Address: 8050 Marshall Drive, Room 205 Lenexa, KS Office: 913-495-5101 Email: Miguel.Hernandez@fda.hhs.gov |
OHAF-West Division 3 | Arkansas, Oklahoma, Texas | Edmundo Garcia* Mailing Address: 4040 N Central Expressway, Room 405 Dallas, TX Office: 214-253-5201 Email: Edmundo.Garcia@fda.hhs.gov |
Karen Daugherty Mailing Address: 4040 N Central Expressway, Room 430 Dallas, TX Office: 214-253-5228 Email: Karen.Daugherty@fda.hhs.gov |
Jessica Hensley Mailing Address: 8050 Marshall Drive, Suite 205 Lenexa, KS Office: 913-495-5183 Email: Jessica.Hensley@fda.hhs.gov |
OHAF-West Division 4 | Arizona, Colorado, New Mexico, Utah Wyoming |
LaTonya Mitchell* Mailing Address: DFC Bldg 20 - W. 6th Ave & Kipling St Room I1021 Lakewood, CO Office: 303-236-3016 Email: LaTonya.mitchell@fda.hhs.gov |
Mark Harris Mailing Address: DFC Bldg 20 - W. 6th Ave & Kipling St Room B1506B Lakewood, CO Office: 303-236-3040 Email: Mark.Harris@fda.hhs.gov |
Kimetha King Mailing Address: DFC Bldg 20 - W. 6th Ave & Kipling St Room 1001A Lakewood, CO Office: 303-236-3041 Email: Kimetha.King@fda.hhs.gov |
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: Darla.Bracy@fda.hhs.gov |
Darlene Almogela - IB1
|
Sergio Chavez Mailing Address: 1431 Harbor Bay Pkwy, Room 246 Alameda, CA Office: 510-337-6886 Email: Sergio.Chavez@fda.hhs.gov |
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: Miriam.Burbach@fda.hhs.gov |
Katie Alford Mailing Address: 22215 26th Ave SE, Suite 210 Bothell, WA Office: 425-302-0440 Email: Katie.Alford@fda.hhs.gov |
Lisa Althar Mailing Address: 22215 26th Ave SE, Suite 210 Bothell, WA Office: 425-302-0420 Email: Lisa.Althar@fda.hhs.gov |
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: Yvette.Arline@fda.hhs.gov |
Miriam Stuckey - IB1
|
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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: Jan.Welch@fda.hhs.gov
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: Joseph.Matrisciano@fda.hhs.gov |
Arduino Frankovic Mailing Address: FDA -158-15 Liberty Avenue, Suite 4041 Jamaica, NY Office: 718-662-5664 Email: Arduino.Frankovic@fda.hhs.gov |
Gina Brackett Mailing Address: 6751 Steger Drive, St041 Cincinnati, OH Office: 513-679-2700 Email: Gina.Brackett@fda.hhs.gov |
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: Blake.Bevill@fda.hhs.gov |
Kathleen Sinninger Mailing Address: 555 Winderley Place, Suite 200 Maitland, FL Office: 407-475-4715 Email: Kathleen.Sinninger@fda.hhs.gov |
Melissa Michurski Mailing Address: 250 Marquette Ave, Suite 600 Minneapolis, MN Office: 612-758-7185 Email: Melissa.Michurski@fda.hhs.gov |
Division 3 | Alaska, Arizona, Arkansas, California, Colorado, Hawaii, Idaho, Montana, Nevada, New Mexico, Oklahoma, Oregon, Texas, Utah, Washington, Wyoming | Shari Shambaugh Mailing Address: 4040 N Central Expressway, Suite 900 Dallas, TX Office: 214-253-5215 Email: Shari.Shambaugh@fda.hhs.gov |
Eric Anderson Mailing Address: 1431 Harbor Bay Pkwy, Room 227 Alameda, CA Office: 510-337-6752 Email: Eric.Anderson@fda.hhs.gov |
Jessica Mu Mailing Address: 19701 Fairchild, RM2153 Irvine, CA Office: 949-608-4477 Email: Jessica.Mu@fda.hhs.gov |
Office of Pharmaceutical Quality Operations
Program Director Name: Alonza Cruse
Office Telephone: 240-402-2540
Email: Alonza.Cruse@fda.hhs.gov
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: Diana.Amador-Toro@fda.hhs.gov |
Karyn Campbell
Nerizza Guerin |
Stephanie Durso Mailing Address: 10 Waterview Blvd. 3rd Floor, Room 300 Parsippany, NJ 07054 Office: 973-331-4911 Email: Stephanie.Durso@fda.hhs.gov |
Division 2 | Alabama, Arkansas, Florida, Georgia, Louisiana, Mississippi, North Carolina, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Virgin Islands |
Monica Maxwell
|
Tamala Magee 4040 N. Central Express Way, Ste. 300 Dallas, TX 75204 214-253-4904 Office: 310-647-2920 Email: Tamala.Magee@fda.hhs.gov |
John Diehl Mailing Address: 4040 N Central Expressway, Room 950 Dallas, TX Office: 214-253-5288 Email: John.Diehl@fda.hhs.gov |
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: Art.Czabaniuk@fda.hhs.gov |
Jeffrey Meng Mailing Address: 300 River Place, 5th Floor, Room 547 Detroit, MI Office: 313-393-8272 Email: Jeffrey.Meng@fda.hhs.gov |
Nicholas Lyons Mailing Address: 550 West Jackson Blvd, Room 1624 Chicago, IL Office: 312-596-4220 Email: Nicholas.Lyons@fda.hhs.gov |
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: Steven.Porter@fda.hhs.gov |
Katherine Jacobitz Mailing Address: 4510 Executive Drive, Room 225 San Diego, CA Office: 619-941-3770 Email: Katherine.Jacobitz@fda.hhs.gov |
Thomas Berry Mailing Address: DFC Bldg 20 - W. 6th Ave & Kipling St Room I1006 Lakewood, CO Email: Thomas.Berry@fda.hhs.gov |
Import Operations
Program Director Name: Dan Solis
Office Telephone: 562-256-9202
Email: Dan.Solis@fda.hhs.gov
- 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: Ruth.Dixon@fda.hhs.gov |
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: Tammara.Threats@fda.hhs.gov |
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: Keith.Jasukaitis@fda.hhs.gov |
Vacant - East Eric Joneson - West |
Sherea Dillon Mailing Address: 550 West Jackson Blvd, Room 1631 Chicago, IL Office: 312-596-4244 Email: Sherea.Dillon@fda.hhs.gov |
Division of West Coast Imports | California, Hawaii, Nevada, Oregon, and Washington. | Vacant 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: Gordon.Chu@fda.hhs.gov |
Lawton Lum Mailing Address: 1431 Harbor Bay Pkwy, Room 250 Alameda, CA Office: 510-337-6792 Email: Lawton.Lum@fda.hhs.gov |
Division of Southwest Imports | Arizona, Colorado, Iowa, Kansas, Missouri, Nebraska, New Mexico, Oklahoma, Texas, Utah, and Wyoming | Todd Cato Mailing Address: 4040 N Central Expressway, Room 300 Dallas, TX Office: 214-253-5284 Email: Todd.Cato@fda.hhs.gov |
Stacy Below Mailing Address: 4040 N Central Expressway, Room 242 Dallas, TX Office: 214-253-5324 Email: Stacy.Below@fda.hhs.gov |
Alex Lopez Mailing Address: 216 West Village Blvd, Suite 107 Laredo, TX Office: 956-721-2431 Email: Alexander.Lopez@fda.hhs.gov |
Division of Northeast Imports | Connecticut, District of Columbia, Delaware, Massachusetts, Maryland, Maine, New York, New Hampshire, Pennsylvania, Rhode island, Virginia, Vermont, and West Virginia | Dawne Hines Mailing Address: FDA -158-15 Liberty Avenue, Suite 3037 Jamaica, NY 11433 Office: 718-662-5461 Email: Dawne.Hines@fda.hhs.gov |
CAPT Nazmul Hassan Mailing Address: FDA-158-15 Liberty Avenue, Suite 3035 Jamaica, NY 11433 Office: 718-662-5707 Email: Nazmul.Hassan@fda.hhs.gov |
Anna Alexander Mailing Address: FDA -158-15 Liberty Avenue, Suite 4046 Jamaica, NY 11433 Office: 718-662-5683 Email: Anna.Alexander@fda.hhs.gov |
Tobacco Operations
Contact Name: Vacant