Company
United StatesCareFusion 303, Inc., San Diego, CA – FDA Inspections
Inspection records and compliance data for CareFusion 303, Inc. in San Diego, California. 8 FDA inspections on record (6 OAI), 1 Form 483, last inspected May 22, 2024.
Company Profile
This profile covers CareFusion 303, Inc. based in San Diego, California, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 6
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 8, 2010. Last inspected May 22, 2024.
Most cited issue areas
- Lack of or inadequate complaint procedures3 inspections
- Lack of or inadequate procedures3 inspections
- Design validation - software validation not performed2 inspections
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 22, 2024 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1234100 |
| March 10, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1166360 |
| April 6, 2020 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1123377 |
| September 6, 2018 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1064813 |
| September 30, 2016 | OAI | Medical Devices & Rad Health · Compliance: Devices | 987844 |
| September 29, 2014 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 893045 |
| December 18, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 812020 |
| October 8, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 685736 |
FDA documents
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Company Information
Name
CareFusion 303, Inc.
FEI Number
2016493
Address
10020 Pacific Mesa Blvd, San Diego, California 92121, United States
Country
United States
ID: e44e5a89-d532-4564-ac5f-1aff2b7d8974