SCSO Group 2 (Division 1), Vacant (NWJ-DO) (973) 331-4914, FAX 973-331-4969

Ann Marie Karnick, SCSO Group 3 (Division 1), (WBAR1-RP) (570) 825-7181 x102, FAX 570-825-7185

Dana Carter, Sr., SCSO Group 4 (Division 1), (NOVA-RP) (703) 538-2176 x 105, FAX 703-538-2628

Randy Baxter, SCSO Group 5 (Division 1), (RAL1-RP) (919) 420-1955, FAX 919-783-7237

Jane Nelson, SCSO Group 6 (Division 1), (JKV-RP) (904) 281-1924 x100, FAX 904-281-1928

Cassandra Winters, SCSO Group 7 (Division 1), (CIN-RP) (513) 246-4134 x1121, FAX 513-381-0219

Danielle Maddox, SCSO Group 8 (Division 1), (NOL-DO) (615) 366-7981, FAX 615-366-7848

Gail Katz, Biologics Consumer Complaints, ELEM, Room 2134, (301) 796-5410

OEI Coordinator, Vacant

Recall Coordinator, Vacant

Division 2

Karlton Watson, (Acting) OBPO Division Director (Division 2) DAL-DO (214) 253-5254, FAX (214) 253-5314

Quality Systems Manager (Division 2) Vacant

Tricia Martinez, (Acting) Director Investigations Branch (Division 2) SAN- RP (210) 308-1414 FAX (210) 308-1420

Catherine Quinlan, (Acting) Director Compliance Branch (Division 2) DET-DO (313) 393-8153 FAX (313) 393-8139

SCSO Group 1 (Division 2, CHI/DET) Vacant

Brent Hall, SCSO Group 2 (Division 2), (DEM-RP) (515) 244-0480 x1000, FAX 515-244-0618

Elisa Fleming, SCSO Group 3 (Division 2), (DAL-DO) (214) 253-5260, FAX 214-253-4997

SCSO Group 4 (Division 2, DAL) Vacant

Alexander Kay, SCSO Group 5 (Division 2), (PS-RP) 98104, (206) 340-8237

Aneel Sandhu, SCSO Group 6 (Division 2), (SAN-DO) (510) 337-6875, FAX 510-337-6702

SCSO Group 7 (Division 2, LOS) Vacant

Gail Katz, Biologics Consumer Complaints, ELEM, Room 2134, (301) 796-5410

OEI Coordinator, Vacant

Thanh Tran, Recall Coordinator, (LOS-DO) (949) 608-3504

Office of Medical Device and Radiological Health Operations

Jan Welch, Program Director, WO, (301) 796-5776

Anne Reid, Deputy Program Director, ATL-DO, (404) 253-1185Vacant, Operations Staff Director

Rhonda Mecl, (612) 758-7198, Acting Staff Director (09/15/17 – 01/15/18)

Dorothy Lee, Foreign Inspection Staff Director, Element, (301) 796-5687

Kristina Donohue, Special Assistant, WO, (301) 796-1423

Lynne Dwyer, Quality System Manager (QSM), NWE-DO, (781) 587-7523

Monica Forrest, Program Training Officer, NWE-DO, (781) 587-7462

Division 1

Joseph Matrisciano, Program Division Director-Division 1 East, NWE-DO, (781) 587-7490

Arduino Frankovic, Director Investigations Branch, NYK-DO, (718) 589-7490

Vacant, Director Compliance Branch

(Bill MacFarland, Acting Compliance Director (301) 796-5547 8/15-11/15/17)

(Gina Brackett, Acting Compliance Director (513)679-2700 x2167 11/15/17-2/15/18)

Eric Joneson, SCSO- Group 1, DET-DO (313) 393-8157

(Katelyn Staub-Zamperini (Pittsburgh RP) 412-644-3394 – Acting 10/1-11/24/2017)

Brian Putz, SCSO- Group 2, DET-DO (313) 393-8237

Lisa Leveille, SCSO- Group 3, NWE-DO (781) 587-7485

Maura Rooney, SCSO- Group 4, NWE-DO (781) 587-7531

Kelli Dobilas, SCSO- Group 5, NWJ-DO (732) 390-3807

(Nicholas Mendiola, NYK-DO (315) 448-1016 Acting 9/17-11/11/2017)

Daniel Tammariello, SCSO- Group 6, PHI-DO (412) 644-3394 x16

Maria Caride, Recall Coordinator, NYK-DO (347) 276-7130

Melinda Ruiz, Recall Coordinator, NYK-DO (718) 662-5470

Division 2/Central

Vacant, Program Division Director, TBD

(Kathleen Sinninger (407) 475-4715 Acting 9/15/17-1/15/18)

Kathleen Sinninger, DIB, (407) 475-4715

(Travis Chapman, Acting – 407-475-4723 9/15/17-1/15/18)

Blake Bevill, DCB, FLA-DO (407) 475-4734

Trang Cox, SCSO- Group 1, ATL-DO (404) 669-4540

Nicole Williams, SCSO- Group 2, CHI-DO (312) 596-4167

Michelle Dunaway, SCSO- Group 3, FLA-DO (561) 416-1101

Mary Kay Concannon, SCSO- Group 4, KAN-DO (314) 645-1167 x124

Vacant, SCSO- Group 5, TBD

(Susan Matthias, Min-DO (612) 758-7137 Acting) 10/1/11/25/2017)

Rhonda Mecl, SCSO- Group 6, MIN-DO (612) 758-7198

(Karen Rodrigues, FLA-DO (305) 816-1448 Acting) 10/1-11/25/2017)

Jose Pedro De Jesus, SCSO- Group 7, SJN-DO (787) 729-8653

Neisa Alonso, Recall Coordinator, FLA-DO (407) 475-4712

Meredith Cobb, Recall Coordinator, FLA-DO (407) 475-4722

Marie Fink, Recall Coordinator, NOL-DO (504) 846-6109

Division 3/West

Vacant, Program Division Director, TBD

(Shari Shambaugh, DAL-DO (214) 253-5215 Acting 9/15/2017-2/15/2018)

Vacant, DIB, TBD

(Eric Anderson SAN-DO (510) 337-6752 Acting 9/15/2017-1/15/2018)

Kelly Sheppard, DCB, LOS-DO (949) 608-4426

Bill Shackelford, SCSO- Group 1, DAL-DO (512) 916-5736

Bryan Love, SCSO- Group 2, DEN-DO (303) 236-3059

Tamala Magee, SCSO- Group 3, LOS-DO (310) 647-2920

Eric Anderson, SCSO- Group 4, SAN-DO (510) 337-6752

(James Hildreth SEA-DO (503)671-1127 Acting 10/2/2017-12/31/2017)

Vanessa Jacobs, SCSO- Group 5, SEA-DO (425) 302-0451

Mary Hole, SCSO- Group 6, SAN-DO (408) 291-7548 x1119

OMDRHO - Topical Points of Contact:

• Complaints: DIBs listed in Divisions above

• Compliance questions: DCBs listed in Divisions above

• Criminal Investigations: DIBs listed in Divisions above

• Device Curriculum Committee Liaison: Monica Forrest, NWE-DO (781) 587-7462

• Device Inspectional Question - ORAHQDeviceInspectionPOC[ta]fda.hhs.gov

• Device Profile and Program Monitor- Division 1 Lisa Leveille NWE-DO (781) 587-7485

• Device Profile and Program Monitor- Division 2 Trang Cox ATL-DO (404) 669-4540

• Device Profile and Program Monitor- Division 3 Bryan Love DEN-DO (303) 236-3059

• Device Registration Monitors - Division 1 Daniel Tammariello PHI-DO (412) 644-3394 x16

• Device Registration Monitors - Division 2 Mary Kay Concannon KAN-DO (314) 645-1167 x124

• Device Registration Monitors - Division 3 Eric Anderson SAN-DO (510) 337-6752

• Device/RH Compliance Cadre calls: Operations Staff Director

• Device/RH Investigator Cadre calls: Operations Staff Director

• Directed Inspection Assignments should be sent to: ORAOORequest[ta]fda.hhs.gov

• Directed Inspection Assignments questions: Operations Staff Director

• ExecSec Requests: ORAOMDRHO-ESREQUESTS[ta]fda.hhs.gov

• FICT: Anne ATL-DO (404) 253-1185 or Bryan Love DEN-DO (303) 236-3059

• Field Bulletins: Operations Staff Director

• Firm FDA-483 Response Letters:

o Division 1: oradevices1firmresponse[ta]fda.hhs.gov

o Division 2: oradevices2firmresponse[ta]fda.hhs.gov

o Division 3: oradevices3firmresponse[ta]fda.hhs.gov

• Foreign Cadre Inspection questions: Foreign Inspection Staff Director

• Foreign Registration Monitor: Althea Williams, Element (301) 796-8389

• Foreign Registration Monitor: Dolores Harper, Element (301) 796-5439

• Health Fraud Monitor: Arduino Frankovic NYK-DO (718) 662-5664

• Import questions: John Verbeten/DIOM (301) 796-6677

• IOM Updates: Contact Program Experts (PEs)

• MDSAP - email ORAHQMDSAP[ta]fda.hhs.gov

• OEI Liaison: Kathleen Sinninger FLA-DO (407) 475-4715

• Policy questions: Dinesh Kumar, OSPOP (240) 402-0372

• Program Expert (PE): Althea Williams, Element (301) 796-8389

• Program Expert (PE): Dolores Harper, Element (301) 796-5439

• Program Training Officer: Monica Forrest, NWE-DO (781) 587-7462

• Quality Management System (QMS): Lynne Dwyer NWE-DO (781) 587-7523

• Radiological Health Inspection questions: Operations Staff Director

• Recalls: Contact Recall Coordinators listed above or emails below

o Division 1: oradevices1recalls[ta]fda.hhs.gov

o Division 2: oradevices2recalls[ta]fda.hhs.gov

o Division 3: oradevices3recalls[ta]fda.hhs.gov

• RPM Updates: Dinesh Kumar, OSPOP (240) 402-0372

• State Contract Monitors (CA): Mary Hole SAN-DO (408) 291-7548 x1119

• State Contract Monitors (TX): Bill Shackelford DAL-DO (512) 916-5736

Office of Pharmaceutical Quality Operations

Alonzo Cruse, Program Director, WO31 RM2526, (240) 402-2540,

Deputy Program Director, Vacant

Kristen DeMaio, Special Assistant, WO31 RM3545, (301)796-4391

Yvonne McKnight, (Acting) Quality Management Specialist PHI-DO, (215) 717-3026, FAX 215-597-4660

Jane Kreis, Program Training Officer, (510) 287-2708

Division of Pharmaceutical Quality Programs (DPQP)

Ann Marie Montemurro, Division Director, ELEM Rm 2032, (301) 796-5521, FAX 301-827-6685

Pharmaceutical Quality Initiatives Branch (PQIB)

Michael Chasey, Branch Chief, ELEM Rm 2028, (301) 796-4516, FAX 301-827-9791

Caryn McNab, Pre Approval Manager (949) 608-4472

Irma Rivera, Drug Registration Monitor, (301) 796-5601

Michael Tollon, Pre Approval Manager (813) 915-7995

Joanne M. Washington, Program Analyst, (301) 796-5743

Pharmaceutical Quality Programs Branch (PQPB)

Paul Perdue, Branch Chief, ELEM Rm 2140, (240) 402-3144, FAX 240-276-4219

Thomas Arista, National Expert, (214) 253-4920

Sharon Thoma, National Expert (612) 758-7159

Ilena Pettit, National Expert (407) 475-4708

Robert Tollefsen, National Expert (425) 302-0360

Justine Tomasso, Program Expert (240) 402-0446

James Dunnie, Program Expert (301) 796-5438

Division of Foreign Pharmaceutical Quality Inspections (DFPQI)

Division Director, Vacant

Foreign Pharmaceutical Quality Inspections Branch 1 (FPQIB1)

Branch Chief, Vacant

Foreign Pharmaceutical Quality Inspections Branch 2 (FPQIB2)

Kevin Gonzalez, Branch Chief, ELEM Rm 2038, (240) 402-0550

Division 1

Diana Amador Toro, Division Director, NWJ-DO, (973) 331-4901, FAX 973-331-4968

Craig Swanson, Deputy Division Director, NWJ-DO, (973) 331-4923, FAX 973-331-4969

William Muszynski, Emergency Response Coordinator, VHS-RP, (973) 331-4919, FAX 856-783-1513

Melba Rivera, QMS, NWJ-DO, (973) 331-4965, FAX 973-331-4969

Jo Ann DeClement, State Liaison, VHS-RP, (856) 290-4007, FAX 856-783-1513

Nancy Rolli, Director Investigation Branch, NWJ-DO, (973) 331-4915, FAX 973-331-4929

Douglas C Kovacs, SCSO, NWJ-DO, (973) 331-4936, FAX 973-331-4969

Stephen J Mottola, SCSO, EBR-RP, (732) 390-3805

Meyer J Slobotsky, SCSO, EBR-RP, (732) 390-3806, FAX 732-390-3830

Margaret M Sands, SCSO, NEW-DO, (781) 587-7483, FAX 781-587-7556

Chad N Thompson, SCSO, Albany-RP, (518) 453-2314 x1016, FAX 518-453-2443

Tara Herrmann, OEI Coordinator, VHS-RP, (856) 290-4030, FAX 856-783-1513

Virginia Seland, Complaint Coordinator, NWJ-DO, (973) 331-4998, FAX 973-331-4969

Karyn Campbell, Director Investigation Branch, PHI-DO, (215) 717-3731, FAX 215-597-4660

Kelly I Anderson, SCSO, BLT-DO, (410) 779-5438, FAX 410-779-5705

John Mastalski, SCSO, Wilmington-RP, (302) 573-6447 x102, FAX 302-573-6398

Paul C Mouris, SCSO, White Plains-RP, (914) 682-2826 x13, FAX 914-682-6170

Matthew A Spataro, SCSO, White Plains-RP (914) 682-2826, x17, FAX 914-682-6170

Valerie Whipp, SCSO, Montrose Metro II, (240) 402-2599

Jacquelyn Gess, Complaint Coordinator, HAR-RP, (717) 541-9924 x12, FAX 717-541-9927

Steven Carter, Director Compliance Branch, PHI-DO, (215) 717-3071, FAX 215-597-8212

Lisa Mathew, Recall Coordinator, NWJ-DO, (973) 331-4917; FAX 973-331-4969

Dellareese Herbert, Recall Coordinator, PHI-DO, (215) 717-3747

Division 2

Program Division Director, Vacant

Director Investigations Branch, Vacant

Charles D Brown, SCSO, DAL-DO, (214) 253-5245, FAX 214-253-5314

Frances L Dejesus, SCSO, SJN-DO, (787) 729-8543, FAX 787-729-8768

Cynthia R Gibson, SCSO, MOB-DO, (251)344-8208x9105, FAX 251-345-7596

Lareese K Thomas, SCSO, Hartfield-RP, (404) 669-4570, FAX 404-669-4443

Jose Martinez, SCSO, SA-RP, (210) 308-1402, FAX 210-308-1420

Karlton T Watson, SCSO, DAL-DO, (214) 253-5254, FAX 214-253-5314

Vincent M Williams, SCSO, Hartfield-RP, (404) 669-4559, FAX 404-669-4443

Director Compliance Branch, Vacant

Kenitra Hewitt, Recall Coordinator DAL-DO, (214) 253-5221, FAX 214-253-5313

Division 3

Art Czabaniuk, Division Director, DET-DO, (313) 393-8154, FAX 313-393-8139

Lisa Joseph, Emergency Response Coordinator, DET-DO, (313) 393-8169, FAX 313-393-8139

Steven Senio, Quality Systems Manager, DET-DO, (313) 393-8221, FAX 313-393-8224

State Liaison, Vacant

Keith Jasukaitis, Director Investigation Branch, DET-DO, (313) 393-8141, FAX 313-393-8139

Steven P Eastham, SCSO, Cincinnati-RP, (513) 246-4134 x1103, FAX 513-381-0219

Carl Huffman, SCSO, KAN-DO, (913) 495-5190, FAX 913-495-5115

Jeffrey D Meng, SCSO, DET-DO, (313) 393-8272, FAX 313-393-8139

Patrick Cummings, SCSO, MIN-DO, (612) 758-7193, FAX 612-334-4131

Dell S Moller, SCSO, Columbus-RP, (614) 227-5780 x1108, FAX 614-227-5795