FDA Inspection
Progressive Dynamics, Inc.Progressive Dynamics, Inc. – FDA Inspection, Sep 26, 2012
Record Details
This FDA Inspection record concerns Progressive Dynamics, Inc., with an inspection on September 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Progressive Dynamics, Inc.
- Inspection Date
- September 26, 2012
- Product Type
- Devices
View Company Profile
ID · f77228f3-e660-459b-9f71-65b81b042c17
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 801070
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Progressive Dynamics, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 5, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Progressive Dynamics, Inc.
- FDA Inspection 921324 - 2015-04-07
- FDA Inspection 657038 - 2010-03-05
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