FDA Inspection
Novadaq Technologies, Inc.Novadaq Technologies, Inc. – FDA Inspection, Jun 30, 2011
Record Details
This FDA Inspection record concerns Novadaq Technologies, Inc., with an inspection on June 30, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Novadaq Technologies, Inc.
- Inspection Date
- June 30, 2011
- Product Type
- Devices
View Company Profile
ID · 7216fc86-d734-4cd9-ba63-c3c494f5fc5c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 735763
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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