FDA Import Refusals - Korea Food

대한민국 제조사, 일반 식품 코드(02-41), 선택 기간 기준 FDA 수입거부 자료입니다. 생성 시각: 2026-07-20 07:53:59.

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2025-01-01
2026-06-24

Charge Codes

Charge IDCharge CodeRefusalsFirmsProduct CodesSectionReason
3846807REFUSAL-3846531003RGN99; 03YGD12; 03YGN99; 04CGT08; 04YGT05; 07IGT03; 07IGY04; 07YGN99; 07YGT99; 14YGT99; 16AGD77; 16AGH28; 16AGT76; 16AGT99; 16MGP03; 16MGP09; 20BGH14; 20TGT05; 24HHT08; 25MCT99; 26BGN99; 26CGN09; 26CGT99; 28BYY60; 37JHP05; 38YGT99807(b)The food is subject to refusal of admission pursuant to Section 807 in that the foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or other establishment.
3600REFUSE EI-360039803RGN99; 03YGN99; 04CGN08; 04CGT99; 04YGT05; 07SGT03; 07YGT99; 16AGT99; 16MGP03; 16MGP09; 16SGY28; 20BGH14; 20TGT05; 23KGN02; 24BHT13; 26BGN99; 26CGN09; 26CGN99; 26CHN09; 27YHT06; 33LGT07; 40BDT99801(a)(1); INSANITARY MANUFACTURING, PROCESSING OR PACKINGThe article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
482NUTRIT LBL-482351503HGT99; 03JGT02; 05BGE99; 05BGT99; 07BGT99; 16MGT09; 21DGC01; 21DGC99; 24AGT99; 24BGE16; 24FGE05; 25LGE12; 25MVT31; 29AEY99; 29AGT99; 29AHI99; 29BET99; 29BGT99; 29YGY99; 30BGT07; 30BGT99; 30YGT99; 40DGE03; 40DVE03; 41BYY99; 41YYY99403(q); 801(a)(3); MisbrandingThe article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
83NO PROCESS-83321802DGN10; 02DGT05; 05BGE99; 05BGT99; 16AET45; 16AET73; 20SGT03; 24BGE16; 24FGE05; 25LGE12; 25MDI31; 29AGE99; 29AGI09; 29AHI99; 29CGT99; 30BGT07; 30BGT99; 30YGT99; 37BDF99; 37JYY99; 38AGT99; 38MVT15; 40DGE03; 40DVE03; 40IGE99402(a)(4), 801(a)(3); ADULTERATIONThe article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
218LIST INGRE-218301003JGT02; 07BGT99; 16MGT09; 24AGT99; 25MDI31; 29AHI99; 29BET99; 29BGT99; 29YGY99; 33YGT99; 41BYY99403(i)(2), 801(a)(3); MISBRANDINGThe article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
324NO ENGLISH-324301403HGT99; 03JGT10; 03JGT99; 07BGT99; 24AGT99; 25MVT31; 29AGT99; 29BET99; 29BGT99; 30BGT07; 30BGT99; 33YGT99; 41BYY99; 41YGT99; 41YYY99403(f), 801(a)(3); MISBRANDINGThe article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
295LISTERIA-29526525PGC11; 25PGD11; 25PGK11; 25PYC11; 25QGT14; 25RGC14; 25SGC14; 25SGT14402(a)(1), 801(a)(3); ADULTERATIONThe article is subject to refusal of admission pursuant to Section 801(a)(3), in that the article appears to contain Listeria monocytogenes, a poisonous and deleterious substance, which may render it injurious to health.
2580MFRHACCP-258023316AEE76; 16AGT28; 16MGD03; 16MGD09; 16MGT03; 16MGT09; 16WGT20; 16YGD04402(a)(4), 801(a)(3)The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a).
308MFR INSAN-30822316AGY01; 16EGD03; 25PGC11; 25PGK11; 25PYC11; 25QGT14; 25RGC14; 25SGC14; 25SGT14801(a)(1); INSANITARY MANUFACTURING, PROCESSING OR PACKINGThe article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
321LACKS N/C-32115503HGT99; 07BGT99; 24AGT99; 29AGT99; 29BET99; 29BGT99; 29YGY99; 41BYY99; 41YYY99403(e)(2), 801(a)(3); MISBRANDINGThe article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
3300ALLERGEN-330014403JGT02; 07BGT99; 16MGT09; 29YGY99403(w) 801(a)(3); MisbrandingThe article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) in that it appears that the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
251POISONOUS-25113316EGD03; 24UGH29; 24UGT29; 24UYY29402(a)(1), 801(a)(3); ADULTERATIONThe article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
62NEEDS FCE-6211802DGN10; 29CHT99; 30YGT99; 37BDF99; 38AGT99; 38MVT15; 40DGE03; 40DVE03; 40IGE99402(a)(4), 801(a)(3); ADULTERATIONIt appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
274COLOR LBLG-2749503YGT12; 30BGT07; 30BGT99; 33EGT06; 33EGT99; 33LYT07; 33YGT99403(k), 801(a)(3); MISBRANDINGThe article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
306INSANITARY-3068216AGY01; 16EGD03402(a)(4), 801(a)(3); ADULTERATIONThe article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
328USUAL NAME-3288625MVT31; 29AEY99; 29AGT99; 29BGT99; 33YGT99; 41YGT99403(i)(1), 801(a)(3); MISBRANDINGThe article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
3821MFR INJ-38217125PGC11; 25PGD11; 25RGC14; 25SGC14; 25SGT14402(a)(4),801(a)(3); ADULTERATIONThe article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that such article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
256INCONSPICU-2566416MGT09; 41BYY99; 41YYY99403(f), 801(a)(3); MISBRANDINGThe article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
320LACKS FIRM-3206425MVT31; 30YGT99; 41BYY99; 41YYY99403(e)(1), 801(a)(3); MISBRANDINGThe article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
241PESTICIDE-2416420AGD14; 22HGH02; 22HGN02; 24TGH99402(a)(2)(B), 801(a)(3); ADULTERATIONThe article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains:
3320TRANSFAT-33206103JGT02403(q), 801(a)(3) ;MISBRANDINGThe product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].
260FALSE-2605229BGT99; 30YGT99403(a)(1), 801(a)(3); MISBRANDINGThe article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
3886FSVP VIO-38865302EFT15; 24TGT29; 28BGT08805, 801(a)(3); FOREIGN SUPPLIER VERIFICATION PROGRAMThe article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it appears that the importer (as defined in section 805 of the FD&C Act) is in violation of section 805.
3898INADPRCCTL-38985314BFI01; 20KYY04; 24DGT13; 25MGE25; 26CYT04402(a)(4), 801(a)(3); ADULTERATIONThe article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health due to inadequate process controls.
11UNSAFE COL-115333EGT06; 33EGT99; 33LYT07; 33YGT99402(c), 801(a)(3); ADULTERATIONThe article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
2300DIETARYLBL-23004329BCT99; 41BYY99; 41YYY99403(s)(2)(B), 801(a)(3), misbrandedThe article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term 'dietary supplement', which term may be modified with the name of such an ingredient.
3864NCONTACT-38643341BYY99; 41YYY99403(y), 801(a)(3); MISBRANDINGThe article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
258FLAVR LBLG-2582133YGT99403(k), 801(a)(3); MISBRANDINGThe article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact.
473LABELING-4732121DGC01; 21DGC99Section 4(a); 801(a)(3) MisbrandingThe article appears in violation of FPLA because of its placement, form and/or contents statement.
9SALMONELLA-92216AGH28; 16MGH03402(a)(1), 801(a)(3); ADULTERATIONThe article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
315ADDED BULK-3151116EGN03402(b)(4), 801(a)(3); ADULTERATIONThe article is subject to refusal of admission pursuant to Section 801(a)(3) in that the food appears to have a substance added to, mixed or packed with it so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.
488HEALTH C-4881141YYT99801(a)(3); 403(r)(1)(A)/(B) misbrandingThe article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
329JUICE %-3291129AHI99403(i)(2), 801(a)(3); MISBRANDINGThe article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that the food purports to be a beverage containing vegetable or fruit juice and does not bear a statement on the label in appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained therein.
3621JUICEHACCP-36211121KHT14 801(a)(3);402(a)(4)The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions, or it may be injurious to health, due to failure of the foreign processor to comply with 21 CFR 120.
3878POISONORD-38781124UGT29402(a)(1), 801(a)(3); ADULTERATIONThe article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance which would ordinarily render the article injurious to health. Contains:
325STD NAME-3251141BYY99403(g)(2), 801(a)(3); MISBRANDINGThe article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(2) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided under Section 401 of the FD&C Act and the article is not labeled with the name specified in the definition and standard, or the label does not bear the common names of optional ingredients (other than spices, flavoring and coloring) present in such food, insofar as may be required by such regulation.
2040SULFITELBL-20401122HGH02403(a)(1), 801(a)(3) ;MISBRANDINGThe article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because 1) it appears to contain sulfites but the label fails to declare the presence of sulfites, a fact material to sulfite-sensitive individuals who must avoid the ingredient due to potential health consequences from its consumption, and 2) it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.
75UNAPPROVED-751141BYY99505(a), 801(a)(3); UNAPPROVED NEW DRUGThe article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
64YELLOW #5-641130BGT07402(c), 403(m), 801(a)(3); ADULTERATION, MISBRANDINGThe food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.