FDA Inspection
Endevr, LLCEndevr, LLC – FDA Inspection, Feb 12, 2014
Record Details
This FDA Inspection record concerns Endevr, LLC, with an inspection on February 12, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Endevr, LLC
- Inspection Date
- February 12, 2014
- Product Type
- Devices
View Company Profile
ID · f0cada15-b33f-433d-8a0e-e4684d3e0056
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 866280
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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