CHANG GUNG BIOTECHNOLOGY CO. LTD. TAISHAN FERMENTATION PLANT
⚠️ Moderate Risk
FEI: 3003732465 • New Taipei City • TAIWAN
FEI Number
3003732465
Location
New Taipei City
Country
TAIWANAddress
No. 1 Nantai Rd., Taishan Dist., New Taipei City, , 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).
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/24/2016 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 8/23/2004 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/23/2004 | 31PGT99TEA SUBSTITUTES, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/23/2004 | 54YBK06BEE POLLEN (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/23/2004 | 54HBK03EVENING PRIMROSE OIL (FATS AND LIPID SUBSTANCES) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is CHANG GUNG BIOTECHNOLOGY CO. LTD. TAISHAN FERMENTATION PLANT's FDA import refusal history?
CHANG GUNG BIOTECHNOLOGY CO. LTD. TAISHAN FERMENTATION PLANT (FEI: 3003732465) has 5 FDA import refusal record(s) in our database, spanning from 8/23/2004 to 5/24/2016.
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. CHANG GUNG BIOTECHNOLOGY CO. LTD. TAISHAN FERMENTATION PLANT's FEI number is 3003732465.
What types of violations has CHANG GUNG BIOTECHNOLOGY CO. LTD. TAISHAN FERMENTATION PLANT received?
CHANG GUNG BIOTECHNOLOGY CO. LTD. TAISHAN FERMENTATION PLANT 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 CHANG GUNG BIOTECHNOLOGY CO. LTD. TAISHAN FERMENTATION PLANT come from?
All FDA import refusal data for CHANG GUNG BIOTECHNOLOGY CO. LTD. TAISHAN FERMENTATION PLANT 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.