FDA Inspection
Somnowell, Inc.Somnowell, Inc. – FDA Inspection, Mar 10, 2016
Record Details
This FDA Inspection record concerns Somnowell, Inc., with an inspection on March 10, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Somnowell, Inc.
- Inspection Date
- March 10, 2016
- Product Type
- Devices
View Company Profile
ID · f7129059-637c-4303-85ea-a368ae075731
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 961419
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR Procedures
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