DADDYBABY CO.,LTD
⚠️ High Risk
FEI: 3007698283 • Fuzhou, Fujian • CHINA
FEI Number
3007698283
Location
Fuzhou, Fujian
Country
CHINAAddress
No. 308 Suan Lingcun, Xincuozhen Fuqing, Fuzhou, Fujian, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/8/2024 | 80FXXMASK, SURGICAL | Division of Southeast Imports (DSEI) | |
| 9/17/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | Division of Southeast Imports (DSEI) | |
| 7/8/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | Division of Southeast Imports (DSEI) | |
| 6/23/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/5/2020 | 73KHAMASK, SCAVENGING | 479DV QUALITY | Division of West Coast Imports (DWCI) |
| 6/1/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is DADDYBABY CO.,LTD's FDA import refusal history?
DADDYBABY CO.,LTD (FEI: 3007698283) has 6 FDA import refusal record(s) in our database, spanning from 6/1/2020 to 10/8/2024.
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. DADDYBABY CO.,LTD's FEI number is 3007698283.
What types of violations has DADDYBABY CO.,LTD received?
DADDYBABY 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 DADDYBABY CO.,LTD come from?
All FDA import refusal data for DADDYBABY 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.