SENKE PHARMACEUTICAL (CHENGDU)
⚠️ Moderate Risk
FEI: 3016686942 • Chengdu, Sichuan • CHINA
FEI Number
3016686942
Location
Chengdu, Sichuan
Country
CHINAAddress
No. 145 Waidong Street, Xinfanzhen Xindou District, Chengdu, Sichuan, 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.
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/17/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of West Coast Imports (DWCI) | |
| 10/22/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of West Coast Imports (DWCI) | |
| 10/13/2020 | 80NZJRESPIRATOR, N95, HOME USE | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 10/13/2020 | 80NZJRESPIRATOR, N95, HOME USE | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 6/24/2020 | 80LYUACCESSORY, SURGICAL APPAREL | 479DV QUALITY | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SENKE PHARMACEUTICAL (CHENGDU)'s FDA import refusal history?
SENKE PHARMACEUTICAL (CHENGDU) (FEI: 3016686942) has 5 FDA import refusal record(s) in our database, spanning from 6/24/2020 to 12/17/2020.
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. SENKE PHARMACEUTICAL (CHENGDU)'s FEI number is 3016686942.
What types of violations has SENKE PHARMACEUTICAL (CHENGDU) received?
SENKE PHARMACEUTICAL (CHENGDU) 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 SENKE PHARMACEUTICAL (CHENGDU) come from?
All FDA import refusal data for SENKE PHARMACEUTICAL (CHENGDU) 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.