FDA Inspection
Dynatronics Corp Chattanooga OperationsDynatronics Corp Chattanooga Operations – FDA Inspection, May 23, 2012
Record Details
This FDA Inspection record concerns Dynatronics Corp Chattanooga Operations, with an inspection on May 23, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 23, 2012
- Product Type
- Devices
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ID · 15fa090f-cfed-4277-b49b-cc3377f0a44d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 783513
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
15- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Dynatronics Corp Chattanooga Operations
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 10, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 10, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 8, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Dynatronics Corp Chattanooga Operations
- FDA Inspection 1019365 - 2017-05-10
- FDA Inspection 917358 - 2015-03-10
- FDA Inspection 610719 - 2009-09-08
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