FDA Inspection
Pulmodyne Inc.Pulmodyne Inc. – FDA Inspection, Mar 22, 2013
Record Details
This FDA Inspection record concerns Pulmodyne Inc., with an inspection on March 22, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pulmodyne Inc.
- Inspection Date
- March 22, 2013
- Product Type
- Devices
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ID · 8dd0ab47-b1f6-4e0e-930e-06b7c41f9587
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 823725
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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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 |
| February 10, 2010 | 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 644965 - 2010-02-10
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