SHIJIAZHUANG AOFEITE IMPORT&EXPORT CO., LTD
⚠️ Moderate Risk
FEI: 3009068676 • Shijiazhuang, HEBEI • CHINA
FEI Number
3009068676
Location
Shijiazhuang, HEBEI
Country
CHINAAddress
East and southwest side in the fourth floor in the NO.202 of Gree supporting industrial park, No.389 of Hengshan street, High-tech Zone, Shijiazhuang, HEBEI, 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).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/27/2020 | 89ISRBAND OR BELT, PELVIC SUPPORT | Division of Southeast Imports (DSEI) | |
| 12/11/2018 | 87HSTAPPARATUS, TRACTION, NON-POWERED | Division of Southeast Imports (DSEI) | |
| 9/28/2016 | 87HSTAPPARATUS, TRACTION, NON-POWERED | Division of Southwest Imports (DSWI) | |
| 2/26/2016 | 89ITWJOINT, ANKLE, EXTERNAL BRACE | Seattle District Office (SEA-DO) | |
| 2/26/2016 | 89ITWJOINT, ANKLE, EXTERNAL BRACE | Seattle District Office (SEA-DO) | |
| 12/5/2014 | 89ITQJOINT, KNEE, EXTERNAL BRACE | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 12/5/2014 | 89ITQJOINT, KNEE, EXTERNAL BRACE | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 12/5/2014 | 89ITQJOINT, KNEE, EXTERNAL BRACE | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 6/4/2014 | 89ISRBAND OR BELT, PELVIC SUPPORT | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is SHIJIAZHUANG AOFEITE IMPORT&EXPORT CO., LTD's FDA import refusal history?
SHIJIAZHUANG AOFEITE IMPORT&EXPORT CO., LTD (FEI: 3009068676) has 9 FDA import refusal record(s) in our database, spanning from 6/4/2014 to 7/27/2020.
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. SHIJIAZHUANG AOFEITE IMPORT&EXPORT CO., LTD's FEI number is 3009068676.
What types of violations has SHIJIAZHUANG AOFEITE IMPORT&EXPORT CO., LTD received?
SHIJIAZHUANG AOFEITE IMPORT&EXPORT 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 SHIJIAZHUANG AOFEITE IMPORT&EXPORT CO., LTD come from?
All FDA import refusal data for SHIJIAZHUANG AOFEITE IMPORT&EXPORT 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.