KONINKLIIJKE PHILIPS N V PHILIPSHEALTHCARE
⚠️ Moderate Risk
FEI: 3030067837 • Bothell, WA • UNITED STATES
FEI Number
3030067837
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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/2/2024 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is KONINKLIIJKE PHILIPS N V PHILIPSHEALTHCARE's FDA import refusal history?
KONINKLIIJKE PHILIPS N V PHILIPSHEALTHCARE (FEI: 3030067837) has 1 FDA import refusal record(s) in our database, spanning from 4/2/2024 to 4/2/2024.
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. KONINKLIIJKE PHILIPS N V PHILIPSHEALTHCARE's FEI number is 3030067837.
What types of violations has KONINKLIIJKE PHILIPS N V PHILIPSHEALTHCARE received?
KONINKLIIJKE PHILIPS N V PHILIPSHEALTHCARE has been cited for 1 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 KONINKLIIJKE PHILIPS N V PHILIPSHEALTHCARE come from?
All FDA import refusal data for KONINKLIIJKE PHILIPS N V PHILIPSHEALTHCARE 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.