Philips North America, LLC
⚠️ High Risk
FEI: 1218950 • Andover, MA • UNITED STATES
FEI Number
1218950
Location
Andover, MA
Country
UNITED STATESAddress
3000 Minuteman Rd, , Andover, MA, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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).
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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.
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 |
|---|---|---|---|
| 10/25/2024 | 74NSAOVER-THE-COUNTER AUTOMATED EXTERNAL DEFIBRILLATOR | Division of West Coast Imports (DWCI) | |
| 12/13/2018 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Division of West Coast Imports (DWCI) | |
| 4/15/2016 | 73CAFNEBULIZER (DIRECT PATIENT INTERFACE) | Florida District Office (FLA-DO) | |
| 9/17/2015 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Cincinnati District Office (CIN-DO) | |
| 3/4/2014 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 1/8/2014 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Los Angeles District Office (LOS-DO) | |
| 1/8/2014 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Los Angeles District Office (LOS-DO) | |
| 1/8/2014 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Los Angeles District Office (LOS-DO) | |
| 12/19/2013 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Los Angeles District Office (LOS-DO) | |
| 8/8/2013 | 73CAWGENERATOR, OXYGEN, PORTABLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 11/5/2012 | 90JAKSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | 341REGISTERED | New York District Office (NYK-DO) |
| 11/5/2012 | 90JAKSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | 341REGISTERED | New York District Office (NYK-DO) |
| 11/5/2012 | 90JAKSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | 341REGISTERED | New York District Office (NYK-DO) |
| 6/26/2012 | 90IZLSYSTEM, X-RAY, MOBILE | New York District Office (NYK-DO) | |
| 11/12/2003 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Detroit District Office (DET-DO) | |
| 6/17/2003 | 94V07TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR | 476NO REGISTR | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Philips North America, LLC's FDA import refusal history?
Philips North America, LLC (FEI: 1218950) has 16 FDA import refusal record(s) in our database, spanning from 6/17/2003 to 10/25/2024.
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. Philips North America, LLC's FEI number is 1218950.
What types of violations has Philips North America, LLC received?
Philips North America, LLC has been cited for 10 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.