Company
CanadaAbbott Point of Care Canada Limited, Nepean, Canada – FDA Inspections
Inspection records and compliance data for Abbott Point of Care Canada Limited in Nepean. 8 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected September 19, 2024.
Company Profile
This profile covers Abbott Point of Care Canada Limited based in Nepean, Canada.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 5
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 1
First inspected November 3, 2008. Last inspected September 19, 2024.
Most cited issue areas
- Design validation - production units1 inspection
- Lack of Written MDR Procedures1 inspection
- Records of complaint investigation1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 19, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1251759 |
| May 19, 2022 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1176613 |
| May 12, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1019209 |
| October 20, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1010306 |
| December 5, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 862058 |
| December 2, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 705411 |
| November 3, 2008 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 551733 |
| November 3, 2008 | VAI | Medical Devices & Rad Health · Compliance: Devices | 551537 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Abbott Point of Care Canada Limited
FEI Number
3005643513
Address
185 Corkstown Rd, Nepean, Canada
Country
Canada
ID: cd452e71-30d5-4307-a3ed-1cf00f2360a3