FDA Inspection
Denovo Products LLCDenovo Products LLC – FDA Inspection, Feb 23, 2018
Record Details
This FDA Inspection record concerns Denovo Products LLC, with an inspection on February 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ebcfed51-1ffb-4b97-b392-75b9f5aadb43
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042008
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.60Identification procedures, 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 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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