EAGLES EQUIPMENT INDUSTRIAL LTD
⚠️ High Risk
FEI: 3023371978 • Sheung Wan • HONG KONG
FEI Number
3023371978
Location
Sheung Wan
Country
HONG KONGAddress
9b 66 Wing Lok St Cheon, , Sheung Wan, , Hong Kong
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/7/2024 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 2/27/2024 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 2/15/2024 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 2/15/2024 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 2/14/2024 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 2/14/2024 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 2/14/2024 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 2/13/2024 | 89IOBLAMP, INFRARED, PHYSICAL MEDICINE | Division of Southeast Imports (DSEI) | |
| 2/7/2024 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | Division of Southeast Imports (DSEI) | |
| 2/2/2024 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 1/25/2024 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/25/2024 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/25/2024 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is EAGLES EQUIPMENT INDUSTRIAL LTD's FDA import refusal history?
EAGLES EQUIPMENT INDUSTRIAL LTD (FEI: 3023371978) has 13 FDA import refusal record(s) in our database, spanning from 1/25/2024 to 6/7/2024.
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. EAGLES EQUIPMENT INDUSTRIAL LTD's FEI number is 3023371978.
What types of violations has EAGLES EQUIPMENT INDUSTRIAL LTD received?
EAGLES EQUIPMENT INDUSTRIAL LTD has been cited for 5 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 EAGLES EQUIPMENT INDUSTRIAL LTD come from?
All FDA import refusal data for EAGLES EQUIPMENT INDUSTRIAL 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.