Caregen Co., Ltd.
⚠️ High Risk
FEI: 3010592110 • Gunpo, Gyeonggi • SOUTH KOREA
FEI Number
3010592110
Location
Gunpo, Gyeonggi
Country
SOUTH KOREAAddress
270 Gongdan-Ro, , Gunpo, Gyeonggi, South Korea
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The 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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/22/2025 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/15/2025 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/12/2025 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/24/2025 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 5/28/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/30/2025 | 53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/18/2024 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/14/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northeast Imports (DNEI) | |
| 8/7/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northeast Imports (DNEI) | |
| 8/4/2024 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/4/2024 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/16/2024 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Southeast Imports (DSEI) | |
| 7/8/2024 | 53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2024 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 5/20/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 237NO PMA | Division of Northeast Imports (DNEI) |
| 5/20/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 237NO PMA | Division of Northeast Imports (DNEI) |
| 5/20/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 237NO PMA | Division of Northeast Imports (DNEI) |
| 5/8/2024 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/8/2024 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/6/2024 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/30/2024 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Southeast Imports (DSEI) | |
| 4/11/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 4/5/2024 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/12/2024 | 60QDJ67LIDOCAINE (ANESTHETIC) | Division of Southeast Imports (DSEI) | |
| 8/30/2023 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2023 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/28/2023 | 78MRESOLUTION, SODIUM HYALURONATE | Division of Southeast Imports (DSEI) | |
| 7/28/2023 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/25/2022 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 11/29/2016 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Seattle District Office (SEA-DO) | |
| 10/12/2016 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Cincinnati District Office (CIN-DO) | |
| 9/29/2016 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/23/2016 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/23/2016 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/28/2016 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/28/2016 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/28/2016 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/28/2016 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/28/2016 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/28/2016 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/28/2016 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/28/2016 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/28/2016 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/9/2015 | 53L10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 10/9/2015 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/1/2015 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 3/9/2012 | 53PD99OTHER COSMETIC RAW MATERIALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/5/2012 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Caregen Co., Ltd.'s FDA import refusal history?
Caregen Co., Ltd. (FEI: 3010592110) has 49 FDA import refusal record(s) in our database, spanning from 1/5/2012 to 12/22/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Caregen Co., Ltd.'s FEI number is 3010592110.
What types of violations has Caregen Co., Ltd. received?
Caregen Co., Ltd. has been cited for 12 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Caregen Co., Ltd. come from?
All FDA import refusal data for Caregen Co., Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.