FDA Inspection
Epiderma IncEpiderma Inc – FDA Inspection, Nov 16, 2015
Record Details
This FDA Inspection record concerns Epiderma Inc, with an inspection on November 16, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Epiderma Inc
- Inspection Date
- November 16, 2015
- Product Type
- Devices
View Company Profile
ID · 330f1822-a5b8-4a98-9d39-e827dabbf077
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 949171
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, 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
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
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