Belle Mud And Salt Dead Sea
⚠️ Moderate Risk
FEI: 3005964713 • Arad • 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.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/15/2011 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 7/15/2011 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 7/15/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/15/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/15/2011 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Belle Mud And Salt Dead Sea's FDA import refusal history?
Belle Mud And Salt Dead Sea (FEI: 3005964713) has 5 FDA import refusal record(s) in our database, spanning from 7/15/2011 to 7/15/2011.
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. Belle Mud And Salt Dead Sea's FEI number is 3005964713.
What types of violations has Belle Mud And Salt Dead Sea received?
Belle Mud And Salt Dead Sea 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 Belle Mud And Salt Dead Sea come from?
All FDA import refusal data for Belle Mud And Salt Dead Sea 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.