FDA Inspection
Custom Ocular ProstheticsCustom Ocular Prosthetics – FDA Inspection, Jul 15, 2014
Record Details
This FDA Inspection record concerns Custom Ocular Prosthetics, with an inspection on July 15, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Custom Ocular Prosthetics
- Inspection Date
- July 15, 2014
- Product Type
- Devices
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ID · 71506c6c-7ae0-4446-bdd0-a448f4110062
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 887634
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Custom Ocular Prosthetics
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 4, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 11, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 1, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Custom Ocular Prosthetics
- FDA Inspection 802528 - 2012-10-04
- FDA Inspection 724123 - 2011-05-11
- FDA Inspection 594992 - 2009-07-01
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