FDA Inspection
Duralife-USA, LLCDuralife-USA, LLC – FDA Inspection, Feb 7, 2017
Record Details
This FDA Inspection record concerns Duralife-USA, LLC, with an inspection on February 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 559362e1-c374-4e9a-956c-1725474e5797
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002898
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(a)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 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 803.17Lack of Written MDR Procedures
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