Wooil C & Tech Corp.
⚠️ Moderate Risk
FEI: 3010176173 • Pyeongtaek, Gyeonggi • SOUTH KOREA
FEI Number
3010176173
Location
Pyeongtaek, Gyeonggi
Country
SOUTH KOREAAddress
28 Poseunggongdanro118beon-Gil, Poseung-Eup, Pyeongtaek, Gyeonggi, 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
FALSE
The 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.
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).
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/23/2009 | 53CY99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | Seattle District Office (SEA-DO) | |
| 12/15/2008 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Wooil C & Tech Corp.'s FDA import refusal history?
Wooil C & Tech Corp. (FEI: 3010176173) has 2 FDA import refusal record(s) in our database, spanning from 12/15/2008 to 1/23/2009.
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. Wooil C & Tech Corp.'s FEI number is 3010176173.
What types of violations has Wooil C & Tech Corp. received?
Wooil C & Tech Corp. has been cited for 4 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 Wooil C & Tech Corp. come from?
All FDA import refusal data for Wooil C & Tech Corp. 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.