Company
United StatesAbbott, Plymouth, MN – FDA Inspections
Inspection records and compliance data for Abbott in Plymouth, Minnesota. 15 FDA inspections on record, last inspected June 28, 2024.
Company Profile
This profile covers Abbott based in Plymouth, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 15
- OAI
- 0
- VAI
- 2
- NAI
- 10
- Unclassified
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected October 24, 2008. Last inspected June 28, 2024.
Most cited issue areas
- Device return/disposal by non-compliant investigator1 inspection
- Sponsor securing investigator compliance1 inspection
- Sponsors' general responsibilities1 inspection
FDA inspections (15)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 28, 2024 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1228934 |
| January 10, 2020 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1117585 |
| June 22, 2018 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1057461 |
| April 26, 2018 | Not classified | Medical Devices & Rad Health | 1071075 |
| April 25, 2018 | Not classified | Medical Devices & Rad Health | 1071072 |
| February 1, 2018 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1055664 |
| May 19, 2017 | Not classified | Medical Devices & Rad Health | 1022314 |
| September 16, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 984890 |
| June 11, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 835900 |
| March 8, 2013 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 821649 |
| October 5, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 748475 |
| November 17, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 635590 |
| November 17, 2009 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 627906 |
| August 20, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 609551 |
| October 24, 2008 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 543715 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Abbott
FEI Number
3005334138
Address
5050 Nathan Ln N, Plymouth, Minnesota 55442, United States
Country
United States
ID: b7d5749c-5854-4f4a-ad2f-fd6002f0d9fe