FDA Inspection
Philips Respironics, Inc.Philips Respironics, Inc. – FDA Inspection, Jun 24, 2011
Record Details
This FDA Inspection record concerns Philips Respironics, Inc., with an inspection on June 24, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Philips Respironics, Inc.
- Inspection Date
- June 24, 2011
- Product Type
- Devices
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ID · 9c755046-b873-4021-b727-b32f8ae8e8a1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 733052
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Philips Respironics, Inc.
16| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 9, 2021 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 10, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 10, 2020 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 21, 2018 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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