Dr. Nona International LTD
⚠️ Moderate Risk
FEI: 3012150015 • Kannot • ISRAEL
FEI Number
3012150015
Location
Kannot
Country
ISRAELAddress
23 Adom st., Kannot industrial Area, Kannot, , 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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/26/2012 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 10/13/2009 | 63RBJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 10/13/2009 | 62WAL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/13/2009 | 62WAL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/13/2009 | 62WAL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/1/2002 | 66FBY99SUPPRESSANT N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dr. Nona International LTD's FDA import refusal history?
Dr. Nona International LTD (FEI: 3012150015) has 6 FDA import refusal record(s) in our database, spanning from 5/1/2002 to 6/26/2012.
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. Dr. Nona International LTD's FEI number is 3012150015.
What types of violations has Dr. Nona International LTD received?
Dr. Nona International 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 Dr. Nona International LTD come from?
All FDA import refusal data for Dr. Nona International 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.