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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. Drug and device firms located outside the United States should report their recall to the Recall Coordinator in the state where your U.S. Agent is located. 

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
oradevices1recalls@fda.hhs.gov
Emma Schaefer Contact
101 W. Broad St.
Suite 400
Falls Church, VA 22046
Phone: 813-915-7968
oradevices1recalls@fda.hhs.gov
Cynthia Aycock Contact
300 River Place Dr.
Ste. 5900
Detroit, MI 48207
P: 313-393-8162
F: 313-393-8139
oradevices1recalls@fda.hhs.gov
Vacant Contact
555 Winderley Place
Suite 200
Maitland, FL 32751
Phone: 407-475-4735
Fax: 407-475-4769
oradevices1recalls@fda.hhs.gov
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 Meredith AndressContact
4121 Carmichael Rd
Suite 307
Montgomery, AL 36106
Phone: 334-273-4788 ext. 106
Fax: 334-273-4790
oradevices2recalls@fda.hhs.gov
Marie Fink Contact
US FDA Metairie Center
2424 Edenborn Avenue, Suite 410
Metairie, LA 70001
Phone: 504-846-6109
Fax: 504-219-8813
oradevices2recalls@fda.hhs.gov
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
oradevices3recalls@fda.hhs.gov
Theresa Kirkham Contact
19701 Fairchild
Irvine, CA 92612
Phone: 949-608-4437
Fax: 949-608-4498
oradevices3recalls@fda.hhs.gov
Paul Frazier Contact
4040 N. Central Expressway, Suite 300
Dallas, TX 75204
Phone: 214-253-5340
Fax: 214-253-5314
oradevices3recalls@fda.hhs.gov
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
orahafeast1recalls@fda.hhs.gov

Randi-Lynn Bodoh Contact
Syracuse Resident Post
620 Erie Blvd., West
Syracuse, NY 13205
Phone: 315-448-0876 x 1011
orahafeast1recalls@fda.hhs.gov
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
orahafeast2recalls@fda.hhs.gov

Nina Patel Contact
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Phone: 410-779-5132
orahafeast2recalls@fda.hhs.gov
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
orahafeast3recalls@fda.hhs.gov
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
orahafeast4recalls@fda.hhs.gov
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
orahafeast5recalls@fda.hhs.gov
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
orahafeast6recalls@fda.hhs.gov
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
orahafwest1recalls@fda.hhs.gov
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations West II IA; KS; MO; NE Shannon Hall Contact
8050 Marshall Drive Suite 205
Lenexa, KS 66214
Phone: 913-495-5160
Fax: 913-495-5105
orahafwest2recalls@fda.hhs.gov
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations West III AR; OK; TX Brandi Williams Contact
4040 N. Central Expressway
Suite 300
Dallas, TX 75204
Phone: 501-324-5257 ext. 103
Fax: 501-324-5080
orahafwest3recalls@fda.hhs.gov
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations West IV AZ; CO; NM; UT; WY Jamie Port Contact
Building 20, Denver Federal Center
6th Avenue & Kipling Street
PO Box 25087
Denver, CO 80225-0087
Phone: 808-404-4628
Fax: 303-236-3551
orahafwest4recalls@fda.hhs.gov
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations West V CA; HI; NV Vacant Contact
1201 Harbor Bay Parkway
Alameda, CA 94502
Phone: 510-337-6898
Fax: 510-337-6705
orahafwest5recalls@fda.hhs.gov
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
orahafwest6recalls@fda.hhs.gov
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
biologicsrecalls@fda.hhs.gov
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
orapharm1recalls@fda.hhs.gov
Dellarese Priester Contact
60 8th Street NE
Suite 102
Atlanta, GA 30309
Phone: 215-717-3747
orapharm1recalls@fda.hhs.gov
Pharmaceutical Division of Pharmaceutical Quality Operations II AL; AR; FL; GA; LA; MS; NC; OK; PR; SC; TN; TX; US Virgin Islands Vacant  Contact
501 West Felix Street Suite 1103
Fort Worth, TX 76115
Phone: 817-334-5218 Ext. 1104
Fax: 817-334-5642
orapharm2recalls@fda.hhs.gov
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
orapharm3recalls@fda.hhs.gov
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
orapharm4recalls@fda.hhs.gov
Tobacco Tobacco Operations All U.S. LCDR Mouhamed HalwaniContact
WO 32 RM 4352
10903 New Hampshire Ave.
Silver Spring, MD 20993
oratobaccorecalls@fda.hhs.gov

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: 

LCDR Mouhamed Halwani
Branch Chief

ORA Office of Policy Compliance & Enforcement
Recall Operations Branch (OPCE ROB)
orarecalloe@fda.hhs.gov

If a physical mailing address is required to transmit documents to OPCE ROB, please contact us at orarecalloe@fda.hhs.gov.

 
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