Company
United StatesAbbott Molecular, Inc., Des Plaines, IL – FDA Inspections
Inspection records and compliance data for Abbott Molecular, Inc. in Des Plaines, Illinois. 18 FDA inspections on record (1 OAI), 1 Form 483, last inspected January 27, 2023.
Company Profile
This profile covers Abbott Molecular, Inc. based in Des Plaines, Illinois, United States.
FDA Inspection History
- FDA inspections
- 18
- OAI
- 1
- VAI
- 7
- NAI
- 8
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected February 13, 2009. Last inspected January 27, 2023.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Documentation1 inspection
- Investigation procedures1 inspection
FDA inspections (18)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 27, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1195852 |
| February 19, 2021 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1136769 |
| August 29, 2019 | Not classified | Medical Devices & Rad Health | 1121009 |
| July 10, 2019 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1098947 |
| September 20, 2018 | NAI | Biologics, Medical Devices & Rad Health · Postmarket Assurance: Devices | 1068081 |
| October 6, 2017 | Not classified | Medical Devices & Rad Health | 1042654 |
| May 4, 2017 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1013090 |
| March 31, 2016 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 964027 |
| February 3, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 956510 |
| July 11, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 884835 |
| February 21, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 822020 |
| July 11, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 790935 |
| June 1, 2011 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 727830 |
| May 24, 2011 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 726590 |
| July 23, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 674227 |
| March 10, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 653998 |
| June 29, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 596362 |
| February 13, 2009 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 562752 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Abbott Molecular, Inc.
FEI Number
3005248192
Address
1300 E Touhy Ave, Des Plaines, Illinois 60018, United States
Country
United States
ID: 0efa8842-5f5e-4dd9-a381-edf99492a332