Shie Ching Hsien Chemical Intl Ltd
⚠️ Moderate Risk
FEI: 3005145608 • Kaohsiungkaohsiung • TAIWAN
FEI Number
3005145608
Location
Kaohsiungkaohsiung
Country
TAIWANAddress
1f No 98 Ho Ping Rd A Lien Hsia, , Kaohsiungkaohsiung, , 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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/18/2009 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 6/18/2009 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 7/1/2005 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/1/2005 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Shie Ching Hsien Chemical Intl Ltd's FDA import refusal history?
Shie Ching Hsien Chemical Intl Ltd (FEI: 3005145608) has 4 FDA import refusal record(s) in our database, spanning from 7/1/2005 to 6/18/2009.
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. Shie Ching Hsien Chemical Intl Ltd's FEI number is 3005145608.
What types of violations has Shie Ching Hsien Chemical Intl Ltd received?
Shie Ching Hsien Chemical Intl Ltd 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 Shie Ching Hsien Chemical Intl Ltd come from?
All FDA import refusal data for Shie Ching Hsien Chemical Intl 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.