FDA Inspection
CareFusion 303, Inc.CareFusion 303, Inc. – FDA Inspection, Oct 8, 2010
Record Details
This FDA Inspection record concerns CareFusion 303, Inc., with an inspection on October 8, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CareFusion 303, Inc.
- Inspection Date
- October 8, 2010
- Product Type
- Devices
View Company Profile
ID · 99fcd28f-62d8-4fd6-a9a6-9de58d77b254
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 685736
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CareFusion 303, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2024 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 10, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 6, 2020 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 6, 2018 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 30, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CareFusion 303, Inc.
- FDA Inspection 1234100 - 2024-05-22
- FDA Inspection 1166360 - 2022-03-10
- FDA Inspection 1123377 - 2020-04-06
- FDA Inspection 1064813 - 2018-09-06
- FDA Inspection 987844 - 2016-09-30
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