FDA Inspection
Dermapac, Inc.Dermapac, Inc. – FDA Inspection, Dec 11, 2015
Record Details
This FDA Inspection record concerns Dermapac, Inc., with an inspection on December 11, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dermapac, Inc.
- Inspection Date
- December 11, 2015
- Product Type
- Devices
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ID · ef2021b7-7a1a-4f23-b926-0bf8d55d2db1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 952155
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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