FDA Inspection
Physio-Control, Inc.Physio-Control, Inc. – FDA Inspection, Nov 18, 2016
Record Details
This FDA Inspection record concerns Physio-Control, Inc., with an inspection on November 18, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4e8da76c-11fd-49ab-8780-4620a3971770
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 994067
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, 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 |
| 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 1111211 - 2019-11-26
- FDA Inspection 1086723 - 2019-03-29
- FDA Inspection 1035043 - 2017-12-15
- FDA Inspection 931792 - 2015-06-26
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