SHENZHEN FREEFLYING IND. & EXP. LTD.
⚠️ Moderate Risk
FEI: 3008973750 • Shenzhen, Guangdong • CHINA
FEI Number
3008973750
Location
Shenzhen, Guangdong
Country
CHINAAddress
810 Dingxin Bldg A, Nanshan District, Shenzhen, Guangdong, 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.
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).
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.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/17/2019 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/27/2013 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Cincinnati District Office (CIN-DO) | |
| 8/27/2013 | 89EGJDEVICE, IONTOPHORESIS, OTHER USES | Cincinnati District Office (CIN-DO) | |
| 8/27/2013 | 89EGJDEVICE, IONTOPHORESIS, OTHER USES | Cincinnati District Office (CIN-DO) | |
| 8/27/2013 | 89EGJDEVICE, IONTOPHORESIS, OTHER USES | Cincinnati District Office (CIN-DO) | |
| 1/28/2013 | 89LPQSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP | Cincinnati District Office (CIN-DO) | |
| 1/24/2013 | 89LPQSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP | Cincinnati District Office (CIN-DO) | |
| 11/13/2012 | 89LPQSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is SHENZHEN FREEFLYING IND. & EXP. LTD.'s FDA import refusal history?
SHENZHEN FREEFLYING IND. & EXP. LTD. (FEI: 3008973750) has 8 FDA import refusal record(s) in our database, spanning from 11/13/2012 to 12/17/2019.
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. SHENZHEN FREEFLYING IND. & EXP. LTD.'s FEI number is 3008973750.
What types of violations has SHENZHEN FREEFLYING IND. & EXP. LTD. received?
SHENZHEN FREEFLYING IND. & EXP. 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 SHENZHEN FREEFLYING IND. & EXP. LTD. come from?
All FDA import refusal data for SHENZHEN FREEFLYING IND. & EXP. 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.