Park Young Jib.
⚠️ Moderate Risk
FEI: 3006785337 • Seoul • SOUTH KOREA
FEI Number
3006785337
Location
Seoul
Country
SOUTH KOREAAddress
#189-2 Heucksuck-Dong, Dongjack-Gd, , 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
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.
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/6/2008 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 6/6/2008 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 6/6/2008 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 6/6/2008 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 6/6/2008 | 53EC07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 6/6/2008 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 6/6/2008 | 53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 6/6/2008 | 63RBJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Baltimore District Office (BLT-DO) | |
| 6/6/2008 | 76EFWTOOTHBRUSH, MANUAL | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Park Young Jib.'s FDA import refusal history?
Park Young Jib. (FEI: 3006785337) has 9 FDA import refusal record(s) in our database, spanning from 6/6/2008 to 6/6/2008.
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. Park Young Jib.'s FEI number is 3006785337.
What types of violations has Park Young Jib. received?
Park Young Jib. has been cited for 9 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 Park Young Jib. come from?
All FDA import refusal data for Park Young Jib. 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.