Tropical Degil Cosmetics Industries Ltd.
⚠️ Moderate Risk
FEI: 3003004720 • Kiryat Shmona • ISRAEL
FEI Number
3003004720
Location
Kiryat Shmona
Country
ISRAELAddress
Kiryat Shmona, , Kiryat Shmona, , 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).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/14/2005 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | 178COL ADDED | New York District Office (NYK-DO) |
| 1/14/2005 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 7/28/2004 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 7/28/2004 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Tropical Degil Cosmetics Industries Ltd.'s FDA import refusal history?
Tropical Degil Cosmetics Industries Ltd. (FEI: 3003004720) has 4 FDA import refusal record(s) in our database, spanning from 7/28/2004 to 1/14/2005.
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. Tropical Degil Cosmetics Industries Ltd.'s FEI number is 3003004720.
What types of violations has Tropical Degil Cosmetics Industries Ltd. received?
Tropical Degil Cosmetics Industries Ltd. 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 Tropical Degil Cosmetics Industries Ltd. come from?
All FDA import refusal data for Tropical Degil Cosmetics Industries 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.