FDA Inspection
CAPTEK, Inc.CAPTEK, Inc. – FDA Inspection, Sep 25, 2009
Record Details
This FDA Inspection record concerns CAPTEK, Inc., with an inspection on September 25, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CAPTEK, Inc.
- Inspection Date
- September 25, 2009
- Product Type
- Devices
View Company Profile
ID · f65c1aa4-280c-439e-bd3e-54014dc18708
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 614651
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(i)Design changes - validation vs. verification
- 21 CFR 820.30(j)Design history file
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