Baron International Trading Inc
⚠️ Moderate Risk
FEI: 3006217535 • Kiryat Ono • ISRAEL
FEI Number
3006217535
Location
Kiryat Ono
Country
ISRAELAddress
8 Montifire Street, , Kiryat Ono, , Israel
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/20/2008 | 76EFWTOOTHBRUSH, MANUAL | New York District Office (NYK-DO) | |
| 1/31/2008 | 65EAL99PEDICULICIDE, N.E.C. | New York District Office (NYK-DO) | |
| 1/31/2008 | 62WAL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | New York District Office (NYK-DO) | |
| 1/31/2008 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Baron International Trading Inc's FDA import refusal history?
Baron International Trading Inc (FEI: 3006217535) has 4 FDA import refusal record(s) in our database, spanning from 1/31/2008 to 8/20/2008.
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. Baron International Trading Inc's FEI number is 3006217535.
What types of violations has Baron International Trading Inc received?
Baron International Trading Inc has been cited for 4 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 Baron International Trading Inc come from?
All FDA import refusal data for Baron International Trading Inc 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.