Company
United StatesAbbott Medical, Sylmar, CA – FDA Inspections
Inspection records and compliance data for Abbott Medical in Sylmar, California. 14 FDA inspections on record (2 OAI), 3 Form 483s, last inspected June 28, 2023.
Company Profile
This profile covers Abbott Medical based in Sylmar, California, United States.
FDA Inspection History
- FDA inspections
- 14
- OAI
- 2
- VAI
- 3
- NAI
- 8
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected July 8, 2009. Last inspected June 28, 2023.
Most cited issue areas
- Lack of or inadequate procedures3 inspections
- Design Validation - Risk analysis not performed/inadequate2 inspections
- Report of risk to health2 inspections
FDA inspections (14)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 28, 2023 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1209394 |
| January 17, 2020 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1120476 |
| August 2, 2019 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1099418 |
| September 20, 2018 | Not classified | Medical Devices & Rad Health | 1122945 |
| February 17, 2017 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1000696 |
| March 24, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 964165 |
| November 24, 2015 | NAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 952517 |
| April 9, 2015 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 921581 |
| April 11, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 876439 |
| August 1, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 843058 |
| October 17, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 803984 |
| May 4, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 779902 |
| September 20, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 747688 |
| July 8, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 602308 |
FDA documents
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Company Information
Name
Abbott Medical
FEI Number
2017865
Address
15900 Valley View Ct, Sylmar, California 91342, United States
Country
United States
ID: 9609a880-3ad7-48ea-905b-9faaf9179e85