FDA Inspection
Ideas For LivingIdeas For Living – FDA Inspection, Nov 30, 2011
Record Details
This FDA Inspection record concerns Ideas For Living, with an inspection on November 30, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ideas For Living
- Inspection Date
- November 30, 2011
- Product Type
- Devices
View Company Profile
ID · c61a52a4-5822-4428-a583-3758e6fba39b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 755454
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
14- 21 CFR 820.80(e)Documentation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - 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 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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