FDA Inspection
Better Health Systems, IncBetter Health Systems, Inc – FDA Inspection, Dec 12, 2014
Record Details
This FDA Inspection record concerns Better Health Systems, Inc, with an inspection on December 12, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Better Health Systems, Inc
- Inspection Date
- December 12, 2014
- Product Type
- Devices
View Company Profile
ID · bf1f770c-0155-4ae9-bc7a-ef408df7eee1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 906936
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR 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 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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