Company
United StatesAbbott Medical, Plano, TX – FDA Inspections
Inspection records and compliance data for Abbott Medical in Plano, Texas. 12 FDA inspections on record (3 OAI), 1 Form 483, last inspected September 19, 2025.
Company Profile
This profile covers Abbott Medical based in Plano, Texas, United States.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 3
- VAI
- 1
- NAI
- 7
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 6, 2009. Last inspected September 19, 2025.
Most cited issue areas
- Design verification - output does not meet input requirement2 inspections
- Individual Report of Malfunction2 inspections
- Lack of or inadequate complaint procedures2 inspections
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 19, 2025 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1276721 |
| September 3, 2021 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1153679 |
| September 15, 2017 | Not classified | Medical Devices & Rad Health | 1042259 |
| April 4, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1007916 |
| August 18, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 985154 |
| November 10, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 947520 |
| July 29, 2015 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 936456 |
| May 16, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 883380 |
| September 14, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 798448 |
| May 2, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 720384 |
| August 25, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 677604 |
| April 6, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 575705 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Abbott Medical
FEI Number
1627487
Address
6901 Preston Rd, Plano, Texas 75024, United States
Country
United States
ID: 2fda0c41-e7d2-42e8-b536-e05ed7d8ba7e