Company
United StatesPhilips North America, LLC, Andover, MA – FDA Inspections
Inspection records and compliance data for Philips North America, LLC in Andover, Massachusetts. 9 FDA inspections on record (4 OAI), 3 Form 483s, last inspected January 16, 2025.
Company Profile
This profile covers Philips North America, LLC based in Andover, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 4
- VAI
- 1
- NAI
- 2
- Unclassified
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected March 10, 2009. Last inspected January 16, 2025.
Most cited issue areas
- Acceptance records1 inspection
- Design validation - user needs and intended uses1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 16, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1260630 |
| August 23, 2019 | Not classified | Medical Devices & Rad Health | 1142575 |
| December 4, 2018 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1073570 |
| July 14, 2017 | Not classified | Medical Devices & Rad Health | 1034836 |
| June 18, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 932660 |
| December 12, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 860079 |
| September 28, 2011 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 747102 |
| December 14, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 701792 |
| March 10, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 569821 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Philips North America, LLC
FEI Number
1218950
Address
3000 Minuteman Rd, Andover, Massachusetts 01810, United States
Country
United States
ID: 79612d5c-f4a6-4cc1-8134-f23502db5bf9