FDA Inspection
Physio-Control, Inc.Physio-Control, Inc. – FDA Inspection, Mar 30, 2009
Record Details
This FDA Inspection record concerns Physio-Control, Inc., with an inspection on March 30, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Physio-Control, Inc.
- Inspection Date
- March 30, 2009
- Product Type
- Devices
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ID · 44f124db-7572-4cae-a7ba-a455aac91af5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 576034
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.100(a)(2)Investigation
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.100(a)(1)Analysis of data/reports from data sources
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.100(a)(2)Investigation procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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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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