FDA Inspection
Permobil IncPermobil Inc – FDA Inspection, Apr 16, 2026
Record Details
This FDA Inspection record concerns Permobil Inc, with an inspection on April 16, 2026, issued by the New Orleans District Office, covering medical devices & rad health.
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ID · 49ca1dc8-057b-4ab2-af30-6ebc9970623a
Inspection Facts
- Inspection number
- 1299994
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.5.1Production and service provision not adequate
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Other FDA inspections of Permobil Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2021 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 11, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 28, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 16, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 21, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Permobil Inc
- FDA Inspection 1149139 - 2021-08-17
- FDA Inspection 1037821 - 2018-01-11
- FDA Inspection 927931 - 2015-05-28
- FDA Inspection 768863 - 2012-02-16
- FDA Inspection 599948 - 2009-07-21
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