FDA Inspection
DynaRad X-Ray, LLCDynaRad X-Ray, LLC – FDA Inspection, Sep 24, 2012
Record Details
This FDA Inspection record concerns DynaRad X-Ray, LLC, with an inspection on September 24, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DynaRad X-Ray, LLC
- Inspection Date
- September 24, 2012
- Product Type
- Devices
View Company Profile
ID · af364fd6-5715-446b-97b4-bae20a65138e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 806938
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
10- 21 CFR 1002.11Lack of required elements
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 1002.11Failure to submit
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Other FDA inspections of DynaRad X-Ray, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 8, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 8, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 30, 2010 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for DynaRad X-Ray, LLC
- FDA Inspection 720727 - 2010-10-08
- FDA Inspection 685196 - 2010-10-08
- FDA Inspection 683675 - 2010-09-30
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