GUANGDONG FAPON BIOTECH CO. LTD.
⚠️ Moderate Risk
FEI: 3012961212 • Dongguan, Guangdong • CHINA
FEI Number
3012961212
Location
Dongguan, Guangdong
Country
CHINAAddress
No. 5 Hualian Rd, Taiwan High-Tech Indstrial Pakr, Songshan Lake, Dongguan, Guangdong, 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
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/19/2018 | 82OTRRESEARCH USE ONLY/IMMUNOLOGY DEVICES | Division of Southeast Imports (DSEI) | |
| 8/17/2015 | 82OTRRESEARCH USE ONLY/IMMUNOLOGY DEVICES | New Orleans District Office (NOL-DO) | |
| 11/5/2013 | 57VH99IN-VITRO DIAG PRODUCTS, N.E.C. | 186INSANITARY | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is GUANGDONG FAPON BIOTECH CO. LTD.'s FDA import refusal history?
GUANGDONG FAPON BIOTECH CO. LTD. (FEI: 3012961212) has 3 FDA import refusal record(s) in our database, spanning from 11/5/2013 to 3/19/2018.
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. GUANGDONG FAPON BIOTECH CO. LTD.'s FEI number is 3012961212.
What types of violations has GUANGDONG FAPON BIOTECH CO. LTD. received?
GUANGDONG FAPON 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 GUANGDONG FAPON BIOTECH CO. LTD. come from?
All FDA import refusal data for GUANGDONG FAPON 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.