FDA Inspection
CrystalBraces, LLC.CrystalBraces, LLC. – FDA Inspection, Sep 23, 2015
Record Details
This FDA Inspection record concerns CrystalBraces, LLC., with an inspection on September 23, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CrystalBraces, LLC.
- Inspection Date
- September 23, 2015
- Product Type
- Devices
View Company Profile
ID · 04f096fa-f658-4526-a6eb-380e6289070d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 942959
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
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