FDA Inspection
Physio-Control, Inc.Physio-Control, Inc. – FDA Inspection, Jan 17, 2014
Record Details
This FDA Inspection record concerns Physio-Control, Inc., with an inspection on January 17, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Physio-Control, Inc.
- Inspection Date
- January 17, 2014
- Product Type
- Devices
View Company Profile
ID · abee02c0-4363-4150-97f4-d0a74d369bec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 863704
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 821.25(c)(3)Quality assurance procedures: 6-month & annual audits
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Physio-Control, Inc.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 26, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 29, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 15, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 18, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Physio-Control, Inc.
- FDA Inspection 1230558 - 2024-04-18
- FDA Inspection 1111211 - 2019-11-26
- FDA Inspection 1086723 - 2019-03-29
- FDA Inspection 1035043 - 2017-12-15
- FDA Inspection 994067 - 2016-11-18
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