FDA Inspection
Pulmodyne Inc.Pulmodyne Inc. – FDA Inspection, Feb 10, 2010
Record Details
This FDA Inspection record concerns Pulmodyne Inc., with an inspection on February 10, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pulmodyne Inc.
- Inspection Date
- February 10, 2010
- Product Type
- Devices
View Company Profile
ID · 5966aa05-0da8-486c-b9c4-55024c5bc24e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 644965
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.25(b)Training records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pulmodyne Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2025 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 |
Other documents for Pulmodyne Inc.
- FDA Inspection 1268055 - 2025-04-22
- FDA Inspection 1039908 - 2018-01-10
- FDA Inspection 941634 - 2015-09-02
- FDA Inspection 823725 - 2013-03-22
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