Hefei Jianqiao Sci-Tech Development Co., Ltd.
⚠️ Moderate Risk
FEI: 3004113610 • Hefei • CHINA
FEI Number
3004113610
Location
Hefei
Country
CHINAAddress
669 Changjiang West Road, Hefei High, , Hefei, , 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 11/20/2014 | 89IPFSTIMULATOR, MUSCLE, POWERED | New Orleans District Office (NOL-DO) | |
| 6/10/2013 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 5/31/2013 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 3/23/2011 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 237NO PMA | San Francisco District Office (SAN-DO) |
| 7/20/2009 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Hefei Jianqiao Sci-Tech Development Co., Ltd.'s FDA import refusal history?
Hefei Jianqiao Sci-Tech Development Co., Ltd. (FEI: 3004113610) has 5 FDA import refusal record(s) in our database, spanning from 7/20/2009 to 11/20/2014.
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. Hefei Jianqiao Sci-Tech Development Co., Ltd.'s FEI number is 3004113610.
What types of violations has Hefei Jianqiao Sci-Tech Development Co., Ltd. received?
Hefei Jianqiao Sci-Tech Development Co., Ltd. has been cited for 6 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 Hefei Jianqiao Sci-Tech Development Co., Ltd. come from?
All FDA import refusal data for Hefei Jianqiao Sci-Tech Development 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.