Philips North America LLC
⚠️ Moderate Risk
FEI: 1000524572 • Bothell, WA • UNITED STATES
FEI Number
1000524572
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
EXPIRED
the product strength differs from, or its purity or quality falls below, that which it purports or is represented to possess in that it is past its labeled expiration date.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/24/2023 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Division of Southeast Imports (DSEI) | |
| 10/8/2020 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Division of Southeast Imports (DSEI) | |
| 7/31/2020 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Division of Southeast Imports (DSEI) | |
| 1/15/2020 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Division of Southeast Imports (DSEI) | |
| 2/1/2019 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/1/2017 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/25/2016 | 74MSXSYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS | Division of Southeast Imports (DSEI) | |
| 9/9/2016 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Florida District Office (FLA-DO) | |
| 10/25/2013 | 74NSAOVER-THE-COUNTER AUTOMATED EXTERNAL DEFIBRILLATOR | New Orleans District Office (NOL-DO) | |
| 6/20/2007 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Chicago District Office (CHI-DO) | |
| 1/4/2006 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | San Francisco District Office (SAN-DO) | |
| 1/4/2006 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | San Francisco District Office (SAN-DO) | |
| 3/12/2003 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Philips North America LLC's FDA import refusal history?
Philips North America LLC (FEI: 1000524572) has 13 FDA import refusal record(s) in our database, spanning from 3/12/2003 to 4/24/2023.
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 North America LLC's FEI number is 1000524572.
What types of violations has Philips North America LLC received?
Philips North America LLC has been cited for 7 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 North America LLC come from?
All FDA import refusal data for Philips North America LLC 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.