CHO-A Pharmaceutical Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF)
For CHO-A Pharmaceutical Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF), import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is KOREA (THE REPUBLIC OF); product is SeeClean-One Eye Drops | SeeClean-One Eye Drops | SeeClean-One Eye Drops; product code is 64 D - - 99 Emollient, Lubricant, N.E.C. | 65 F - - 06 Water, Purified (Eyewash) | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C; date published is 11/17/2022; address is 318 Gwangjeong-Ro , Haman-Myeon , Haman, Gyeongsangnam KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- CHO-A Pharmaceutical Co., Ltd. verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- KOREA (THE REPUBLIC OF) verified
- Address
- 318 Gwangjeong-Ro , Haman-Myeon , Haman, Gyeongsangnam KOREA (THE REPUBLIC OF) verified
- Date published
- 11/17/2022 verified
- Product code
- 64 D - - 99 Emollient, Lubricant, N.E.C. | 65 F - - 06 Water, Purified (Eyewash) | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. each item verified
- Product
- SeeClean-One Eye Drops | SeeClean-One Eye Drops | SeeClean-One Eye Drops each item verified
- FDA notes
- The product does not meet requirements of section 505G, under which a product is deemed to be GRASE and not a new drug. FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “SeeClean-1 Eye Drops” is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Accordingly, this product appears to be an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). | The product does not meet requirements of section 505G, under which a product is deemed to be GRASE and not a new drug. FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “SeeClean-1 Eye Drops” is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Accordingly, this product appears to be an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). | The product does not meet requirements of section 505G, under which a product is deemed to be GRASE and not a new drug. FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “SeeClean-1 Eye Drops” is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Accordingly, this product appears to be an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). each item verified
What the source says
CHO-A Pharmaceutical Co., Ltd. Date Published : 11/17/2022 318 Gwangjeong-Ro , Haman-Myeon , Haman, Gyeongsangnam KOREA (THE REPUBLIC OF) 64 D - - 99 Emollient, Lubricant, N.E.C. Date Published: 11/17/2022 Desc: SeeClean-One Eye Drops Notes: The product does not meet requirements of section 505G, under which a product is deemed to be GRASE and not a new drug. FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “SeeClean-1 Eye Drops” is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Accordingly, this product appears to be an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). 65 F - - 06 Water, Purified (Eyewash) Date Published: 11/17/2022 Desc: SeeClean-One Eye Drops Notes: The product does not meet requirements of section 505G, under which a product is deemed to be GRASE and not a new drug. FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “SeeClean-1 Eye Drops” is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Accordingly, this product appears to be an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. Date Published: 11/17/2022 Desc: SeeClean-One Eye Drops Notes: The product does not meet requirements of section 505G, under which a product is deemed to be GRASE and not a new drug. FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “SeeClean-1 Eye Drops” is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Accordingly, this product appears to be an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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