Tks International Co Ltd
⚠️ Moderate Risk
FEI: 3007537168 • Kaohsiung Hsienkaohsiung Hsien • TAIWAN
FEI Number
3007537168
Location
Kaohsiung Hsienkaohsiung Hsien
Country
TAIWANAddress
No 1 Lane 625min Yu Rdlu Chu Hsiang, , Kaohsiung Hsienkaohsiung Hsien, , Taiwan
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/24/2010 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 11/24/2010 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 11/24/2010 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 11/24/2010 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Tks International Co Ltd's FDA import refusal history?
Tks International Co Ltd (FEI: 3007537168) has 4 FDA import refusal record(s) in our database, spanning from 11/24/2010 to 11/24/2010.
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. Tks International Co Ltd's FEI number is 3007537168.
What types of violations has Tks International Co Ltd received?
Tks International Co Ltd 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 Tks International Co Ltd come from?
All FDA import refusal data for Tks International 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.