Philips Oral Healthcare Inc
⚠️ Moderate Risk
FEI: 1000126901 • Bothell, WA • UNITED STATES
FEI Number
1000126901
Location
Bothell, WA
Country
UNITED STATESAddress
22100 Bothell Everett Hwy, , Bothell, WA, United States
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/10/2025 | 79NRJULTRASOUND, SKIN PERMEATION | Division of Southeast Imports (DSEI) | |
| 10/27/2023 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/16/2023 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Division of Northeast Imports (DNEI) | |
| 6/19/2018 | 90MJSCONTRAST MEDIA, ULTRASOUND | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/8/2017 | 76JEQTOOTHBRUSH, POWERED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Philips Oral Healthcare Inc's FDA import refusal history?
Philips Oral Healthcare Inc (FEI: 1000126901) has 5 FDA import refusal record(s) in our database, spanning from 6/8/2017 to 11/10/2025.
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. Philips Oral Healthcare Inc's FEI number is 1000126901.
What types of violations has Philips Oral Healthcare Inc received?
Philips Oral Healthcare Inc 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 Philips Oral Healthcare Inc come from?
All FDA import refusal data for Philips Oral Healthcare Inc 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.