FDA Inspection
Pulmodyne Inc.Pulmodyne Inc. – FDA Inspection, Apr 22, 2025
Record Details
This FDA Inspection record concerns Pulmodyne Inc., with an inspection on April 22, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 663aa426-401e-4b92-ae80-4f066ff2501f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1268055
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(a)Design control - no procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pulmodyne Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 10, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 2, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 22, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 10, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pulmodyne Inc.
- FDA Inspection 1039908 - 2018-01-10
- FDA Inspection 941634 - 2015-09-02
- FDA Inspection 823725 - 2013-03-22
- FDA Inspection 644965 - 2010-02-10
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