FDA Inspection
Penrad Technologies, Inc.Penrad Technologies, Inc. – FDA Inspection, Sep 19, 2014
Record Details
This FDA Inspection record concerns Penrad Technologies, Inc., with an inspection on September 19, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Penrad Technologies, Inc.
- Inspection Date
- September 19, 2014
- Product Type
- Devices
View Company Profile
ID · 9189080f-e47b-40ed-af87-78c2bbadf278
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 896783
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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