FDA Inspection
Diopsys, Inc.Diopsys, Inc. – FDA Inspection, Mar 1, 2010
Record Details
This FDA Inspection record concerns Diopsys, Inc., with an inspection on March 1, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Diopsys, Inc.
- Inspection Date
- March 1, 2010
- Product Type
- Devices
View Company Profile
ID · 57828fd6-e931-4568-bb6e-296787575f3f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 651054
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
15- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(a)Process control procedures
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Other FDA inspections of Diopsys, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 11, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Diopsys, Inc.
- FDA Inspection 947353 - 2015-11-02
- FDA Inspection 744141 - 2011-08-11
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