FDA Inspection
Philips Respironics, Inc.Philips Respironics, Inc. – FDA Inspection, Apr 15, 2014
Record Details
This FDA Inspection record concerns Philips Respironics, Inc., with an inspection on April 15, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Philips Respironics, Inc.
- Inspection Date
- April 15, 2014
- Product Type
- Devices
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ID · cb4095db-6607-48fd-bc2a-5d01cd1f60a0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 873805
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
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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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