FDA Inspection
Physio-Control, Inc.Physio-Control, Inc. – FDA Inspection, Nov 26, 2019
Record Details
This FDA Inspection record concerns Physio-Control, Inc., with an inspection on November 26, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Physio-Control, Inc.
- Inspection Date
- November 26, 2019
- Product Type
- Devices
View Company Profile
ID · 553e627d-e2fd-46a2-9bb7-b072f764443c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1111211
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.52(b)(2)Death
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
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 |
| 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 |
| June 26, 2015 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Physio-Control, Inc.
- FDA Inspection 1230558 - 2024-04-18
- FDA Inspection 1086723 - 2019-03-29
- FDA Inspection 1035043 - 2017-12-15
- FDA Inspection 994067 - 2016-11-18
- FDA Inspection 931792 - 2015-06-26
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