Chunghwa Chemical Synthesis & Biotech Co., Ltd
⚠️ Moderate Risk
FEI: 3002806677 • New Taipei City, Taipei • TAIWAN
FEI Number
3002806677
Location
New Taipei City, Taipei
Country
TAIWANAddress
1 Tung-Hsing Street, Shu-Lin District, , New Taipei City, Taipei, 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
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).
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).
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.
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/9/2018 | 65QCS22METHOCARBAMOL (RELAXANT) | Division of Northeast Imports (DNEI) | |
| 8/24/2012 | 54HIS99FATS AND LIPID SUBSTANCES, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/24/2012 | 54HIS99FATS AND LIPID SUBSTANCES, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/24/2012 | 54HIS99FATS AND LIPID SUBSTANCES, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/24/2012 | 54HIS99FATS AND LIPID SUBSTANCES, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/24/2012 | 54HIS99FATS AND LIPID SUBSTANCES, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/24/2012 | 54HIS99FATS AND LIPID SUBSTANCES, N.E.C. | Division of Southeast Imports (DSEI) | |
| 2/20/2009 | 65QDY22METHOCARBAMOL (RELAXANT) | 186INSANITARY | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Chunghwa Chemical Synthesis & Biotech Co., Ltd's FDA import refusal history?
Chunghwa Chemical Synthesis & Biotech Co., Ltd (FEI: 3002806677) has 8 FDA import refusal record(s) in our database, spanning from 2/20/2009 to 1/9/2018.
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. Chunghwa Chemical Synthesis & Biotech Co., Ltd's FEI number is 3002806677.
What types of violations has Chunghwa Chemical Synthesis & Biotech Co., Ltd received?
Chunghwa Chemical Synthesis & Biotech Co., Ltd has been cited for 5 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 Chunghwa Chemical Synthesis & Biotech Co., Ltd come from?
All FDA import refusal data for Chunghwa Chemical Synthesis & Biotech 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.