Huons Co., Ltd.
⚠️ Moderate Risk
FEI: 3007163376 • Jecheon, Chungcheongbuk • SOUTH KOREA
FEI Number
3007163376
Location
Jecheon, Chungcheongbuk
Country
SOUTH KOREAAddress
100 Bio-Valley-Ro, , Jecheon, Chungcheongbuk, South Korea
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
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.
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/21/2024 | 60CCK04EPINEPHRINE (ADRENERGIC) | Division of Southeast Imports (DSEI) | |
| 3/21/2024 | 65RCK19SODIUM CHLORIDE (REPLENISHER) | 472NO ENGLISH | Division of Southeast Imports (DSEI) |
| 6/21/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 237NO PMA | Division of West Coast Imports (DWCI) |
| 7/10/2018 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/12/2011 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/10/2005 | 55RP74DEXTROSE (PHARMACEUTIC NECESSITY) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Huons Co., Ltd.'s FDA import refusal history?
Huons Co., Ltd. (FEI: 3007163376) has 6 FDA import refusal record(s) in our database, spanning from 3/10/2005 to 3/21/2024.
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. Huons Co., Ltd.'s FEI number is 3007163376.
What types of violations has Huons Co., Ltd. received?
Huons Co., Ltd. has been cited for 6 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 Huons Co., Ltd. come from?
All FDA import refusal data for Huons 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.