POWECOM
⚠️ Moderate Risk
FEI: 3016608144 • Guangdong Province • CHINA
FEI Number
3016608144
Location
Guangdong Province
Country
CHINAAddress
No 43,Tuanjie Rd,Huadushiling Leather City, Huadu, , Guangdong Province, , 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.
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/3/2021 | 80QKUNON-NIOSH-APPROVED DISPOSABLE FILTERING FACEPIECE RESPIRATORS (FFRS) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 9/15/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 8/31/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | Division of Southeast Imports (DSEI) | |
| 8/4/2020 | 80NZJRESPIRATOR, N95, HOME USE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 7/27/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Northern Border Imports (DNBI) | |
| 7/13/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 7/13/2020 | 80FXXMASK, SURGICAL | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 7/8/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 7/8/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 6/25/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is POWECOM's FDA import refusal history?
POWECOM (FEI: 3016608144) has 10 FDA import refusal record(s) in our database, spanning from 6/25/2020 to 11/3/2021.
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. POWECOM's FEI number is 3016608144.
What types of violations has POWECOM received?
POWECOM has been cited for 4 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 POWECOM come from?
All FDA import refusal data for POWECOM 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.