LEADS (CHINA) BIOTECH CO LTD
⚠️ Moderate Risk
FEI: 3014680994 • Zhangzhou • CHINA
FEI Number
3014680994
Location
Zhangzhou
Country
CHINAAddress
198 Yintai East Road, Changtai County, Zhangzhou, , 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
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/27/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northern Border Imports (DNBI) | |
| 7/27/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northern Border Imports (DNBI) | |
| 7/27/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northern Border Imports (DNBI) | |
| 7/27/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northern Border Imports (DNBI) | |
| 7/27/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northern Border Imports (DNBI) | |
| 7/27/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is LEADS (CHINA) BIOTECH CO LTD's FDA import refusal history?
LEADS (CHINA) BIOTECH CO LTD (FEI: 3014680994) has 6 FDA import refusal record(s) in our database, spanning from 7/27/2020 to 7/27/2020.
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. LEADS (CHINA) BIOTECH CO LTD's FEI number is 3014680994.
What types of violations has LEADS (CHINA) BIOTECH CO LTD received?
LEADS (CHINA) BIOTECH CO LTD has been cited for 3 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 LEADS (CHINA) BIOTECH CO LTD come from?
All FDA import refusal data for LEADS (CHINA) 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.