Philips Medical Systems Nederland B.V.
⚠️ Moderate Risk
FEI: 3000976525 • Eindhoven, Noord-Brabant • NETHERLANDS
FEI Number
3000976525
Location
Eindhoven, Noord-Brabant
Country
NETHERLANDSAddress
High Tech Campus 36, , Eindhoven, Noord-Brabant, Netherlands
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.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
Frequently Asked Questions
What is Philips Medical Systems Nederland B.V.'s FDA import refusal history?
Philips Medical Systems Nederland B.V. (FEI: 3000976525) has 1 FDA import refusal record(s) in our database, spanning from 12/8/2014 to 12/8/2014.
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 Medical Systems Nederland B.V.'s FEI number is 3000976525.
What types of violations has Philips Medical Systems Nederland B.V. received?
Philips Medical Systems Nederland B.V. has been cited for 2 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 Medical Systems Nederland B.V. come from?
All FDA import refusal data for Philips Medical Systems Nederland B.V. 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.