Woojin T.N.D Co.
⚠️ Moderate Risk
FEI: 3006520091 • Seoul • SOUTH KOREA
FEI Number
3006520091
Location
Seoul
Country
SOUTH KOREAAddress
624-2 Ilwon-Dong, Gangnam-Gu, , Seoul, , 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
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/1/2008 | 79KGXTAPE AND BANDAGE, ADHESIVE | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/18/2007 | 73BWINEEDLE, ACUPUNCTURE | 3260NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 12/18/2007 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Woojin T.N.D Co.'s FDA import refusal history?
Woojin T.N.D Co. (FEI: 3006520091) has 3 FDA import refusal record(s) in our database, spanning from 12/18/2007 to 2/1/2008.
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. Woojin T.N.D Co.'s FEI number is 3006520091.
What types of violations has Woojin T.N.D Co. received?
Woojin T.N.D Co. has been cited for 2 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 Woojin T.N.D Co. come from?
All FDA import refusal data for Woojin T.N.D Co. 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.