GUANGDONG QIAN JING TESTING CO., LTD.
⚠️ Moderate Risk
FEI: 3016612383 • Jieyang, Guangdong • CHINA
FEI Number
3016612383
Location
Jieyang, Guangdong
Country
CHINAAddress
Floor 2, Building B And Floor 3, Building D, No. 30, Development Zone, Liusha, Puning City, , Jieyang, 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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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 |
|---|---|---|---|
| 10/15/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | 479DV QUALITY | Division of West Coast Imports (DWCI) |
| 7/20/2020 | 73KHAMASK, SCAVENGING | Division of Southeast Imports (DSEI) | |
| 7/15/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GUANGDONG QIAN JING TESTING CO., LTD.'s FDA import refusal history?
GUANGDONG QIAN JING TESTING CO., LTD. (FEI: 3016612383) has 3 FDA import refusal record(s) in our database, spanning from 7/15/2020 to 10/15/2020.
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. GUANGDONG QIAN JING TESTING CO., LTD.'s FEI number is 3016612383.
What types of violations has GUANGDONG QIAN JING TESTING CO., LTD. received?
GUANGDONG QIAN JING TESTING 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 QIAN JING TESTING CO., LTD. come from?
All FDA import refusal data for GUANGDONG QIAN JING TESTING 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.