WAVE CORPORATION
⚠️ Moderate Risk
FEI: 3015481059 • Shizuoka-Ken • JAPAN
FEI Number
3015481059
Location
Shizuoka-Ken
Country
JAPANAddress
10-15 Ysyukicho Aoi-Ku, , Shizuoka-Ken, , Japan
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
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.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/1/2020 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 3/30/2020 | 53LF03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 3/30/2020 | 53LF03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 3/30/2020 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 3/12/2020 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is WAVE CORPORATION's FDA import refusal history?
WAVE CORPORATION (FEI: 3015481059) has 5 FDA import refusal record(s) in our database, spanning from 3/12/2020 to 5/1/2020.
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. WAVE CORPORATION's FEI number is 3015481059.
What types of violations has WAVE CORPORATION received?
WAVE CORPORATION has been cited for 5 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 WAVE CORPORATION come from?
All FDA import refusal data for WAVE CORPORATION 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.