TAIZHOU MEDICAL CITY BIOBANK TEC
⚠️ Moderate Risk
FEI: 3016669520 • Taizhou City • CHINA
FEI Number
3016669520
Location
Taizhou City
Country
CHINAAddress
1 Yaocheng Ave, , Taizhou City, , China
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 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/26/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is TAIZHOU MEDICAL CITY BIOBANK TEC's FDA import refusal history?
TAIZHOU MEDICAL CITY BIOBANK TEC (FEI: 3016669520) has 1 FDA import refusal record(s) in our database, spanning from 5/26/2020 to 5/26/2020.
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. TAIZHOU MEDICAL CITY BIOBANK TEC's FEI number is 3016669520.
What types of violations has TAIZHOU MEDICAL CITY BIOBANK TEC received?
TAIZHOU MEDICAL CITY BIOBANK TEC has been cited for 1 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 TAIZHOU MEDICAL CITY BIOBANK TEC come from?
All FDA import refusal data for TAIZHOU MEDICAL CITY BIOBANK TEC 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.