Top Greats Biotech
⚠️ Moderate Risk
FEI: 2000029209 • Yeongkang, TW-TNN • TAIWAN
FEI Number
2000029209
Location
Yeongkang, TW-TNN
Country
TAIWANAddress
No. 53 Alley 2 Lane 279 Chung Cheng Road, , Yeongkang, TW-TNN, 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
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/5/2012 | 36BHT99SYRUPS AND MOLASSES, N.E.C. | 324NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 7/5/2012 | 21WHT06PAPAYA (PAPAW), TOPPING OR SYRUP | 324NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 2/27/2012 | 29YHE99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 2/27/2012 | 29YHT99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Top Greats Biotech's FDA import refusal history?
Top Greats Biotech (FEI: 2000029209) has 4 FDA import refusal record(s) in our database, spanning from 2/27/2012 to 7/5/2012.
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. Top Greats Biotech's FEI number is 2000029209.
What types of violations has Top Greats Biotech received?
Top Greats Biotech 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 Top Greats Biotech come from?
All FDA import refusal data for Top Greats Biotech 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.