FDA Inspection
Flex Operating Room, LLCFlex Operating Room, LLC – FDA Inspection, Jun 18, 2019
Record Details
This FDA Inspection record concerns Flex Operating Room, LLC, with an inspection on June 18, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · eabad08a-3f6c-450e-8006-a085add0f571
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1093686
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.100(a)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 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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