Besmed Health Business Corporation
⚠️ Moderate Risk
FEI: 3003256355 • New Taipei City • TAIWAN
FEI Number
3003256355
Location
New Taipei City
Country
TAIWANAddress
Wu-Ku District, Lane 116; No. 5 Wu-Kong 2nd Road, New Taipei City, , Taiwan
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 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.
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).
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.
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/29/2023 | 85HHECUP, MENSTRUAL | Division of West Coast Imports (DWCI) | |
| 10/4/2004 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 10/2/2003 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 2/26/2002 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Southwest Import District Office (SWI-DO) | |
| 2/26/2002 | 97U09ULTRASOUND PRODUCT FOR NON-MEDICAL USE | Southwest Import District Office (SWI-DO) | |
| 2/26/2002 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Southwest Import District Office (SWI-DO) | |
| 2/26/2002 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Besmed Health Business Corporation's FDA import refusal history?
Besmed Health Business Corporation (FEI: 3003256355) has 7 FDA import refusal record(s) in our database, spanning from 2/26/2002 to 3/29/2023.
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. Besmed Health Business Corporation's FEI number is 3003256355.
What types of violations has Besmed Health Business Corporation received?
Besmed Health Business Corporation 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 Besmed Health Business Corporation come from?
All FDA import refusal data for Besmed Health Business Corporation 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.