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  1. Industry Guidance For Recalls

ORA Recall Coordinators

 

FDA recall coordinators are aligned in program-based divisions: Division of Medical Devices and Radiological Health, Division of Human and Animal Food Operations (includes cosmetics), Division of Biological Products, Division of Pharmaceutical Quality Operations and Tobacco Operations. Establishments outside the United States should continue to contact the recall branch in the Office of Strategic Planning and Operational Policy.

For new recalls, use the table below to locate the recall coordinator assigned for your product type and location.

Product Type Division Firm's State Recall Coordinator
Medical Device Division of Medical Device and Radiological Health Operations I CT; DC; DE; IN; KY; MA; MD; ME; MI; NH; NJ; NY; OH; PA; RI; VA; VT; WV Andrew LangContact
6751 Steger Drive
Cincinnati, OH 45237
P: 513-679-2700 x2177
F: 513-679-2773
[email protected]

Melinda Ruiz Contact
222 Bloomingdale Rd.
Suite 406
White Plains, NY 10605
Phone: 914-682-2826 ext. 15
[email protected]

Cynthia Aycock Contact
300 River Place Dr.
Ste. 5900
Detroit, MI 48207
P: 313-393-8162
F: 313-393-8139
[email protected]
Medical Device Division of Medical Device and Radiological Health Operations II AL; FL; GA; IA; IL; KS; LA; MN; MO; MS; NC; ND; NE; PR; SC; SD; TN; US Virgin Islands; WI Lisa Warner Contact
555 Winderley Place
Suite 200
Maitland, FL 32751
Phone: 407-475-4735
Fax: 407-475-4769
[email protected]

Meredith AndressContact
4121 Carmichael Rd
Suite 307
Montgomery, AL 36106
Phone: 334-273-4788 ext. 106
Fax: 334-273-4790
[email protected]

Marie Fink Contact
US FDA Metairie Center
2424 Edenborn Avenue, Suite 410
Metairie, LA 70001
Phone: 504-846-6109
Fax: 504-219-8813
[email protected]
Medical Device Division of Medical Device and Radiological Health Operations III AK; AR; AZ; CA; CO; HI; ID; MT; NM; NV; OK; OR; TX; UT; WA; WY Mark ChanContact
96 North Third Street, Room 420
San Jose, CA 95112
Phone: 408-291-7548 x 1108
Fax: 408-291-7228
[email protected]

Theresa Kirkham Contact
19701 Fairchild
Irvine, CA 92612
Phone: 949-608-4437
Fax: 949-608-4498
[email protected]

Paul Frazier Contact
4040 N. Central Expressway, Suite 300
Dallas, TX 75204
Phone: 214-253-5340
Fax: 214-253-5314
[email protected]
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations East I CT; MA; ME; NH; NY; RI; VT Melissa A. Henaghan Contact
Albany Resident Post
One Winners Circle, Suite 110
Albany NY 12205
Phone: 518-453-2314 x 1017
Fax: 518-453-2443
[email protected]

Randi-Lynn Bodoh Contact
Syracuse Resident Post
620 Erie Blvd., West
Syracuse, NY 13205
Phone: 315-448-0876 x 1011
[email protected]
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations East II DC; DE; MD; NJ; PA; VA; WV Ruark Lanham Contact
900 US Customhouse, Suite 904
200 Chestnut Street
Philadelphia, PA 19106
Phone: 215-717-3738
Fax: 215-517-6649
[email protected]

Nina Patel Contact
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Phone: 410-779-5132
[email protected]
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations East III GA; NC; SC Emma NesbitContact
60 Eighth Street, NE
Atlanta, GA 30309
Phone: 404-253-1224
Fax: 404-253-1201
[email protected]
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations East IV FL; PR; US Virgin Islands Wanda J. Torres Contact
466 Fernandez Juncos Avenue
San Juan, PR 00901-3223
Phone: 787-729-8709
Fax: 787-729-8826
[email protected]
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations East V AL; KY; LA; MS; OH; TN Caitlin Almonrode Contact
404 BNA Drive, Suite 500
Nashville, TN 37217
Phone: 615-366-7859
[email protected]
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations East VI IL; IN; MI Michael Larson Contact
300 River Place, Suite 5900
Detroit, MI 48207
Phone: 313-393-8118
Fax: 313-393-8139
[email protected]
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations West I MN; ND; SD; WI Kristine Zuroski Contact
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Phone: 612-758-7120
Fax: 612-334-4134
[email protected]
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations West II IA; KS; MO; NE Matthew Sleeter Contact
8050 Marshall Drive Suite 205
Lenexa, KS 66214
Phone: 913-495-5151
Fax: 913-495-5105
[email protected]
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations West III AR; OK; TX Casey Hamblin Contact
4040 N. Central Expressway
Suite 300
Dallas, TX 75204
Phone: 214-253-5222
Fax: 214-253-5314
[email protected]
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations West IV AZ; CO; NM; UT; WY Patricia D. Stahnke Contact
Building 20, Denver Federal Center
6th Avenue & Kipling Street
PO Box 25087
Denver, CO 80225-0087
Phone: 303-236-3045
Fax: 303-236-3551
[email protected]
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations West V CA; HI; NV Marjorie Schultz Contact
1201 Harbor Bay Parkway
Alameda, CA 94502
Phone: 510-337-6898
Fax: 510-337-6705
[email protected]
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations West VI AK; ID; MT; OR; WA Anh Trinh NguyenContact
22215 26th Ave. SE, Suite 210
Bothell, WA 98021
Phone: 425-302-0467
Fax: 425-302-0403
[email protected]
Biologics Division of Biological Products Operations I All U.S. Thanh B TranContact
19701 Fairchild
Irvine, CA 92612
Phone: 949-608-3504
Fax: 949-608-4401
[email protected]
Pharmaceutical Division of Pharmaceutical Quality Operations I CT; DC; DE; MA; MD; ME; NH; NJ; NY; PA; RI; VA; VT; WV Lisa Mathew Contact
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Phone: 973-331-4917
Fax: 973-331-4969
[email protected]

Dellarese Priester Contact
60 8th Street NE
Suite 102
Atlanta, GA 30309
Phone: 215-717-3747
[email protected]
Pharmaceutical Division of Pharmaceutical Quality Operations II AL; AR; FL; GA; LA; MS; NC; OK; PR; SC; TN; TX; US Virgin Islands Kenitra Hewitt Contact
501 West Felix Street Suite 1103
Fort Worth, TX 76115
Phone: 817-334-5218 Ext. 1104
Fax: 817-334-5642
[email protected]
Pharmaceutical Division of Pharmaceutical Quality Operations III IA; IL; IN; KY; KS; MI; MN; MO; ND; NE; OH; SD; WI Mennie ThompsonContact
550 West Jackson Blvd., #1625
Chicago, IL 60661
Phone: 312-596-4239
Fax: 312-596-4125
[email protected]
Pharmaceutical Division of Pharmaceutical Quality Operations IV AK; AZ; CA; CO; HI; ID; MT; NM; NV; OR; UT; WA; WY Farhana KhanContact
22215 26th Ave. SE
Suite 210
Bothell, WA 98021
Phone: 425-302-0361
[email protected]
Tobacco Tobacco Operations All U.S. Cecilia M. WolyniakContact
WO 32 RM 4352
10903 New Hampshire Ave.
Silver Spring, MD 20993
Phone: 301-796-8209
Fax: 301-847-8635
[email protected]

ORA Headquarters

For general recall inquiries, including guidance for foreign firms recalling products exported to the USA and FDA's 3rd party contract for Recall Audit Checks.

Cecilia M. Wolyniak
ORA
Office of Strategic Planning and Operational Policy
Recall Branch

WO 32 RM 4352
10903 New Hampshire Ave.
Silver Spring, MD 20993
Phone: 301-796-8209
Fax: 301-847-8635
[email protected]

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