Sea Of Spa Labs Ltd.
⚠️ Moderate Risk
FEI: 3010755718 • 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 9/30/2015 | 66PAL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Cincinnati District Office (CIN-DO) | |
| 8/20/2014 | 66GBY25DIMETHICONE 350 (SURGICAL/PROSTHETIC AID) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/20/2014 | 66PBY07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/20/2014 | 66PBY07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/20/2014 | 66PBY07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/7/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Sea Of Spa Labs Ltd.'s FDA import refusal history?
Sea Of Spa Labs Ltd. (FEI: 3010755718) has 6 FDA import refusal record(s) in our database, spanning from 8/7/2014 to 9/30/2015.
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. Sea Of Spa Labs Ltd.'s FEI number is 3010755718.
What types of violations has Sea Of Spa Labs Ltd. received?
Sea Of Spa Labs 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 Sea Of Spa Labs Ltd. come from?
All FDA import refusal data for Sea Of Spa Labs 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.