PANASONIC CORPORATION INDUSTRIAL SOLUTIONS COMPANY
⚠️ Moderate Risk
FEI: 3003178358 • Osaka, Osaka • JAPAN
FEI Number
3003178358
Location
Osaka, Osaka
Country
JAPANAddress
1006, OAZA KADOMA,, Oazakadoma, Kadoma, Osaka, Osaka, 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
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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 |
|---|---|---|---|
| 2/15/2019 | 74OEDANTIMICROBIAL BLOOD PRESSURE CUFF | Division of Northern Border Imports (DNBI) | |
| 7/1/2016 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 8/19/2015 | 76JEQTOOTHBRUSH, POWERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is PANASONIC CORPORATION INDUSTRIAL SOLUTIONS COMPANY's FDA import refusal history?
PANASONIC CORPORATION INDUSTRIAL SOLUTIONS COMPANY (FEI: 3003178358) has 3 FDA import refusal record(s) in our database, spanning from 8/19/2015 to 2/15/2019.
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. PANASONIC CORPORATION INDUSTRIAL SOLUTIONS COMPANY's FEI number is 3003178358.
What types of violations has PANASONIC CORPORATION INDUSTRIAL SOLUTIONS COMPANY received?
PANASONIC CORPORATION INDUSTRIAL SOLUTIONS COMPANY 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 PANASONIC CORPORATION INDUSTRIAL SOLUTIONS COMPANY come from?
All FDA import refusal data for PANASONIC CORPORATION INDUSTRIAL SOLUTIONS COMPANY 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.