| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
| Food and Drug Administration | | 5100 Paint Branch Parkway, HFS-681 | | College Park, MD 20993 | |
| DATE: | January 11, 2015 | | TO: | Chungnam Kangkyung Traditional Salted Fish Union | | ADDRESS: | 198 Hwangsan Kangkyung-eup, Nonsan-gun, Nonsan, Chungcheongnamdo 320-902 KOREA, REPUBLIC OF | | Subject: | Food Facility Registration - Biennial Renewal Not Submitted |
Dear Responsible Official: | | | The Food and Drug Administration (FDA) has determined that your facility has not renewed its food facility registration, as required by section 415(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 350d(a)(3)]. Under section 415(a)(3) of the Act, your facility is required to submit to FDA a renewal registration containing the information described in section 415(a)(2) of the Act, including any changes to such information since your facility submitted your preceding registration or registration renewal, every even-numbered year during the period beginning on October 1 and ending December 31. | | | As a responsible official of a facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the food you distribute are in compliance with the Act and applicable FDA regulations. FDA뭩 registration regulations require the owner, operator, or agent in charge of a food facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, or an individual authorized by this facility's owner, operator, or agent in charge, to register such facility with FDA (see 21 CFR 1.225). Section 415(a)(3) of the Act requires the registrant for such a food facility to renew the facility뭩 registration with FDA every other year. | | | | Our records indicate that, to date, you have not submitted a registration renewal to FDA, as required by section 415(a)(3) of the Act. The failure of a food facility to renew its registration with FDA, as required by section 415(a)(3) of the FD&C Act, means that the facility has failed to register in accordance with section 415. The failure to register a food facility in accordance with section 415 is a prohibited act under section 301(dd) of the FD&C Act (21 U.S.C. 331(dd)). We request that you, or an authorized individual, re-register your food facility by completing and submitting your registration to FDA using FDA Form 3537 to FDA. You can submit your registration to FDA on-line at https://www.access.fda.gov/. You may obtain a paper copy of FDA Form 3537 by writing to the U.S. Food and Drug Administration/Food Facility Registration, 5100 Paint Branch Parkway, HFS-681, College Park, MD 20993, or by requesting the form by phone at 800-216-7331 or 301-575-0156. When you receive the form, you must fill it out completely and legibly and return it to the address above or fax it to (301) 436-2804. | | | | If your facility has a new owner, the former owner must cancel the facility뭩 registration as specified in 21 CFR 1.235 within 60 calendar days of the change, and the new owner must re-register the facility as specified in 21 CFR 1.231 (21 CFR 1.234(b)). A facility cancelling its registration must do so within 60 calendar days of the reason for the cancellation (e.g., facility goes out of business or comes under new ownership), and in accordance with 21 CFR 1.235. | | | | FDA's booklet, "What You Need to Know About Registration of Food Facilities" provides information on registration, including biennial registration renewal and registration cancellation. If you need additional information about food facility registration, you may call the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156 or write to FDA at the following address: | U.S. Food and Drug Administration, HFS-681
Food Facility Registration
5100 Paint Branch Parkway
College Park, MD 20993 | | | | If you have any questions about this letter, please call this office at 1-800-216-7331. |
Sincerely,
FDA Unified Registration and Listing and Prior Notice System Helpdesk.
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Food Facility Name:
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Kanggyung Pogoo Salted Fish Shop
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Food Facility Registration Number:
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13137151232
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PIN:
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2B9i6BDf
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