Pat Spitzig
Senior Policy Analyst
FDA-CDRH-OSB
1350 Piccard Dr. (HFZ-500)
Rockville, MD 20850
301-594-2812
fax: 301-594-2965
e-mail: pfs@cdrh.fda.gov
Sharon L. Hansen, Ph.D.
Scientific Expert, DCLD, CDRH, FDA
2098 Gaither Rd.
Rockville, MD 20850
301-594-4595
fax: 301-594-5940
e-mail: slh@cdrh.fda.gov
Louis J. Kaufman
Special Assistant for Enforcement
DOE I, OC, CDRH, FDA
2094 Gaither Road (HFZ-320)
Rockville, MD 20850
301-594-4598 x 179
fax: 301-594-4636
e-mail: ljk@cdrh.fda.gov
Adrianne Galdi
Director
Divison of Enforcement I
OC, CDRH, FDA
2094 Gaither Road (HFZ-320)
Rockville, MD 20850
301-594-4586 x 141
fax: 301-594-4636
e-mail: axg@cdrh.fda.gov
Joseph L. Salyer, RS, MPH
Regulatory Operations Officer
DOE I, OC, CDRH, FDA
2094 Gaither Road (HFZ-323)
Rockville, MD 20850
301-594-4595 x 175
fax: 301-594-4636
e-mail: jws@cdrh.fda.gov
William Duffell, Jr., Ph.D.
Vice President of Clinical and Regulatory Affairs
Cyberonics, Inc.
16511 Space Center Blvd.
Suite 600
Houston, TX 77058
281-228-7223
fax: 281-228-7211
e-mail: whd@cyberonics.com
Kaiser Aziz, Ph.D.
Associate Director
Division of Clinical Laboratory Devices
FDA
2098 Gaither Road
Rockville, MD 20850
301-594-3084
fax: 301-594-5941
e-mail: kja@cdrh.fda.gov
George Flick, Jr., Ph.D.
University Distinguished Professor
Food Science and Technology
Food Science and Technology Building (0418)
Virginia Polytechnic Institute and State University
Blacksburg, VA 24061
540-231-6965
fax: 540-231-9293
e-mail: flickg@vt.edu
Michael Jahncke, Ph.D.
Superintendent, Seafood Specialist
Virginia Seafood Research and Extension Center
102 S. King St.
Hampton, VA 23669
757-727-4861
fax: 757-727-4871
e-mail: mjahncke@vt.edu
| Norman Wong
Engineer
National Medical Device Expert USFDA
22201 23rd Dr. S.E.
Bothell, WA 98021
425-483-4935
fax: 425-483-4996
e-mail: nwong@ora.fda.gov
Patricia B. Shrader, Esq.
Director Corporate Regulatory Affairs
Becton Dickinson biosciences
P.O. Box 999 MC640
Sparks, MD 21152
410-316-4464
fax: 410-316-4258
e-mail:patricia_b_shrader@ms.bd.com
Mike Johnston
Quality Engineer
Becton Dickinson Biosciences
P.O. Box 999 MC980
Sparks, MD 21152
410-771-0100, ext. 6641
fax: 410-773-6490
e-mail: mike_johnston@ms.bd.com
Tony Chan, MBA, MSQA
Quality Advisor
Guidant Corporation
Vascular Intervention Group
P.O. Box 9018
Temecula, CA 92589
909-914-2626
fax: 909-914-2055
e-mail: tchan@guidant.com
Leif Olsen
Vice President, Regulatory Affairs
BioWhittaker, Inc.
8830 Biggs Ford Road
Walkersville, mD 21793-0127
301-898-7025, ext. 2313
fax: 301-845-6452
e-mail: leif@biowhittaker.com
Steve E. Maschino
Director of Quality Assurance
Cyberonics
16511 Space Center Blvd.
Suite 600
Houston, TX 77058
281-228-7200, ext. 232
direct dial: 281-228-7232
fax: 281-218-9332
e-mail: SEM@cyberonics.com
Robert Smallwood
Compliance Consultant
Taratec Development Corporation
220 Continental Drive
Suite 203
Newark, DE 19713
302-368-4040
fax: 302-368-5162
email: rsmallwood@taratec.com
www.taratec.com
Jackelyn Rodriguez, CQA
Quality Assurance Manager
BioEnterics Corporation
1035 Cindy Lane
Carpinteria, CA 93013
805-684-3045
fax: 805-684-0812
jackelynr@bioentrics.com
|