亚洲精品一区二区国产精华液丨97狠狠狠狼鲁亚洲综合网丨国模大尺度福利视频在线丨国产在线视欧美亚综合丨色综合久久综合欧美综合网

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