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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 Address Phone/Fax Email
Biologics Division of Biological Products Operations I All U.S. Thanh B Tran 19701 Fairchild Irvine, CA 92612

Phone: 949-608-3504

Fax: 949-608-4401

 biologicsrecalls@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  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
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations East I CT; MA; ME; NH; NY; RI; VT Randi-Lynn Bodoh  Syracuse Resident Post 620 Erie Blvd., West Syracuse, NY 13205

Phone: 315-448-0876 x 1011

Fax: 518-453-2443

 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 900 US Customhouse, Suite 904 200 Chestnut Street Philadelphia, PA 19106

Phone: 215-717-3738

Fax: 215-517-6649

 orahafeast2recalls@fda.hhs.gov
Human and Animal Food & Cosmetics Division of Human and Animal Food Operations East II DC; DE; MD; NJ; PA; VA; WV Nina Patel 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 Nesbit  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 VACANT 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  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 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 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 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  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 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  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 Nguyen 22215 26th Ave. SE, Suite 210 Bothell, WA 98021

Phone: 425-302-0467

Fax: 425-302-0403

 orahafwest6recalls@fda.hhs.gov
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 Lang 6751 Steger Drive Cincinnati, OH 45237

Phone: 513-679-2700 x2177

Fax: 513-679-2773

 oradevices1recalls@fda.hhs.gov
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 Emma Schaefer 101 W. Broad St. Suite 400 Falls Church, VA 22046 Phone: 813-915-7968 oradevices1recalls@fda.hhs.gov
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 Cynthia Aycock 300 River Place Dr. Ste. 5900 Detroit, MI 48207

Phone: 313-393-8162

Fax: 313-393-8139

 oradevices1recalls@fda.hhs.gov
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 VACANT 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 Andress 4121 Carmichael Rd Suite 307 Montgomery, AL 36106

Phone: 334-273-4788 ext. 106

Fax: 334-273-4790

 oradevices2recalls@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 Marie Fink   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 Chan 96 North Third Street, Room 420 San Jose, CA 95112

Phone: 408-291-7548 x 1108

Fax: 408-291-7228

 oradevices3recalls@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 Theresa Kirkham 19701 Fairchild Irvine, CA 92612

Phone: 949-608-4437

Fax: 949-608-4498

 oradevices3recalls@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 Paul Frazier  4040 N. Central Expressway, Suite 300 Dallas, TX 75204

Phone: 214-253-5340

Fax: 214-253-5314

 oradevices3recalls@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 10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054

Phone: 973-331-4917

Fax: 973-331-4969

 orapharm1recalls@fda.hhs.gov
Pharmaceutical Division of Pharmaceutical Quality Operations I CT; DC; DE; MA; MD; ME; NH; NJ; NY; PA; RI; VA; VT; WV Dellarese Priester 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 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 Thompson  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 Khan  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 Halwani  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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