FDA Inspection
Accurate Set IncAccurate Set Inc – FDA Inspection, Jan 28, 2011
Record Details
This FDA Inspection record concerns Accurate Set Inc, with an inspection on January 28, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Accurate Set Inc
- Inspection Date
- January 28, 2011
- Product Type
- Devices
View Company Profile
ID · 4135a975-cb49-4a43-9b0b-a36eb1589f22
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 709082
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
15- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Accurate Set Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 13, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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