GLOBAL POINT INJECTION MOLDING
⚠️ Moderate Risk
FEI: 3017044157 • Dongguan, Guangdong • CHINA
FEI Number
3017044157
Location
Dongguan, Guangdong
Country
CHINAAddress
Phase 3 Xicheng, Industrial Zone, 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
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/22/2022 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 7/18/2022 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 6/30/2022 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is GLOBAL POINT INJECTION MOLDING's FDA import refusal history?
GLOBAL POINT INJECTION MOLDING (FEI: 3017044157) has 3 FDA import refusal record(s) in our database, spanning from 6/30/2022 to 7/22/2022.
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. GLOBAL POINT INJECTION MOLDING's FEI number is 3017044157.
What types of violations has GLOBAL POINT INJECTION MOLDING received?
GLOBAL POINT INJECTION MOLDING 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 GLOBAL POINT INJECTION MOLDING come from?
All FDA import refusal data for GLOBAL POINT INJECTION MOLDING 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.