FDA Inspection
Vigor Therapy Equipment LLCVigor Therapy Equipment LLC – FDA Inspection, Apr 25, 2014
Record Details
This FDA Inspection record concerns Vigor Therapy Equipment LLC, with an inspection on April 25, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Vigor Therapy Equipment LLC
- Inspection Date
- April 25, 2014
- Product Type
- Devices
View Company Profile
ID · f25c2147-23cb-4d96-a472-21f02da87502
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 875868
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
15- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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