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 In this section:

                Industry Guidance For Recalls

Industry Guidance For Recalls Home
          Safety
          Recalls, Market Withdrawals, & Safety Alerts
          Industry Guidance For Recalls
          ORA Recall CoordinatorsIndustry Guidance For Recalls ORA Recall Coordinators
  
  	
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    PrintFDA 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 CoordinatorMedical 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**Contact
			6751 Steger Drive
			Cincinnati, OH 45237
			P: 513-679-2700 x2177
			F: 513-679-2773oradevices1recalls@fda.hhs.gov

			**Emma Schaefer**Contact

			101 W. Broad St.
			Suite 400
			Falls Church, VA 22046
			Phone: 813-915-7968oradevices1recalls@fda.hhs.gov

			**Cynthia Aycock**Contact

			300 River Place Dr.
			Ste. 5900
			Detroit, MI 48207
			P: 313-393-8162
			F: 313-393-8139oradevices1recalls@fda.hhs.gov

			**Vacant**Contact

			555 Winderley Place
			Suite 200
			Maitland, FL 32751
			Phone: 407-475-4735
			Fax: 407-475-4769oradevices1recalls@fda.hhs.govMedical 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**Contact
			4121 Carmichael Rd
			Suite 307
			Montgomery, AL 36106
			Phone: 334-273-4788 ext. 106
			Fax: 334-273-4790oradevices2recalls@fda.hhs.gov

			**Marie Fink**Contact

			US FDA Metairie Center
			2424 Edenborn Avenue, Suite 410
			Metairie, LA 70001
			Phone: 504-846-6109
			Fax: 504-219-8813oradevices2recalls@fda.hhs.govMedical 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**Contact
			96 North Third Street, Room 420
			San Jose, CA 95112
			Phone: 408-291-7548 x 1108
			Fax: 408-291-7228oradevices3recalls@fda.hhs.gov

			**Theresa Kirkham**Contact

			19701 Fairchild
			Irvine, CA 92612
			Phone: 949-608-4437
			Fax: 949-608-4498oradevices3recalls@fda.hhs.gov

			**Paul Frazier**Contact

			4040 N. Central Expressway, Suite 300
			Dallas, TX 75204
			Phone: 214-253-5340
			Fax: 214-253-5314oradevices3recalls@fda.hhs.govHuman 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: 518-453-2443orahafeast1recalls@fda.hhs.gov
			**Randi-Lynn Bodoh**Contact

			Syracuse Resident Post
			620 Erie Blvd., West
			Syracuse, NY 13205
			Phone: 315-448-0876 x 1011orahafeast1recalls@fda.hhs.govHuman 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: 215-517-6649orahafeast2recalls@fda.hhs.gov
			**Nina Patel**Contact

			6000 Metro Drive, Suite 101
			Baltimore, MD 21215
			Phone: 410-779-5132orahafeast2recalls@fda.hhs.govHuman and Animal Food & Cosmetics
			Division of Human and Animal Food Operations East III
			GA; NC; SC
			**Emma Nesbit**Contact
			60 Eighth Street, NE
			Atlanta, GA 30309
			Phone: 404-253-1224
			Fax: 404-253-1201orahafeast3recalls@fda.hhs.govHuman 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: 787-729-8826orahafeast4recalls@fda.hhs.govHuman 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: 615-366-7859orahafeast5recalls@fda.hhs.govHuman 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: 313-393-8139orahafeast6recalls@fda.hhs.govHuman 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: 612-334-4134orahafwest1recalls@fda.hhs.govHuman 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: 913-495-5105orahafwest2recalls@fda.hhs.govHuman 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: 501-324-5080orahafwest3recalls@fda.hhs.govHuman 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: 303-236-3551orahafwest4recalls@fda.hhs.govHuman 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: 510-337-6705orahafwest5recalls@fda.hhs.govHuman and Animal Food & Cosmetics
			Division of Human and Animal Food Operations West VI
			AK; ID; MT; OR; WA
			**Anh Trinh Nguyen**Contact
			22215 26th Ave. SE, Suite 210
			Bothell, WA 98021
			Phone: 425-302-0467
			Fax: 425-302-0403orahafwest6recalls@fda.hhs.govBiologics
			Division of Biological Products Operations I
			All U.S.
			AL; AK; AZ; AR; CA; CO; CT; DC; DE; FL; GA; HI; ID; IL; IN; IA; KS; KY; LA; ME; MD; MA; MI; MN; MS; MO; MT; NE; NV; NH; NJ; NM; NY; NC; ND; OH; OK; OR; PA; RI; SC; SD; TN; TX; UT; VT; VA; WA; WV; WI; WY; AS; DC; FM; GU; MH; MP; PW; PR; VI; US Virgin Islands;
			**Thanh B Tran**Contact
			19701 Fairchild
			Irvine, CA 92612
			Phone: 949-608-3504
			Fax: 949-608-4401biologicsrecalls@fda.hhs.govPharmaceutical
			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: 973-331-4969orapharm1recalls@fda.hhs.gov

			**Dellarese Priester**Contact

			60 8th Street NE
			Suite 102
			Atlanta, GA 30309
			Phone: 215-717-3747orapharm1recalls@fda.hhs.govPharmaceutical
			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: 817-334-5642orapharm2recalls@fda.hhs.govPharmaceutical
			Division of Pharmaceutical Quality Operations III
			IA; IL; IN; KY; KS; MI; MN; MO; ND; NE; OH; SD; WI
			**Mennie Thompson**Contact
			550 West Jackson Blvd., #1625
			Chicago, IL 60661
			Phone: 312-596-4239
			Fax: 312-596-4125orapharm3recalls@fda.hhs.govPharmaceutical
			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: 425-302-0361orapharm4recalls@fda.hhs.govTobacco
			Tobacco Operations
			All U.S.
			AL; AK; AZ; AR; CA; CO; CT; DC; DE; FL; GA; HI; ID; IL; IN; IA; KS; KY; LA; ME; MD; MA; MI; MN; MS; MO; MT; NE; NV; NH; NJ; NM; NY; NC; ND; OH; OK; OR; PA; RI; SC; SD; TN; TX; UT; VT; VA; WA; WV; WI; WY; AS; DC; FM; GU; MH; MP; PW; PR; VI; US Virgin Islands;
			**LCDR Mouhamed Halwani**Contact
			WO 32 RM 4352
			10903 New Hampshire Ave.
			Silver Spring, MD 20993oratobaccorecalls@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.

                                                                                  Content current as of:
      03/11/2020Industry Guidance For Recalls
 
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