Fally Logistics Ltd
⚠️ Moderate Risk
FEI: 3008841704 • Hong Kong • HONG KONG
FEI Number
3008841704
Location
Hong Kong
Country
HONG KONGAddress
2 Xing Wei Rd, , Hong Kong, , Hong Kong
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).
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.
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 |
|---|---|---|---|
| 1/20/2012 | 89LBFDEVICE, THERAPY, DIRECT CURRENT, LOW INTENSITY | Cincinnati District Office (CIN-DO) | |
| 1/6/2012 | 89NZFMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 1/6/2012 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 1/6/2012 | 89NZFMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Fally Logistics Ltd's FDA import refusal history?
Fally Logistics Ltd (FEI: 3008841704) has 4 FDA import refusal record(s) in our database, spanning from 1/6/2012 to 1/20/2012.
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. Fally Logistics Ltd's FEI number is 3008841704.
What types of violations has Fally Logistics Ltd received?
Fally Logistics Ltd has been cited for 3 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 Fally Logistics Ltd come from?
All FDA import refusal data for Fally Logistics 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.