FDA Inspection
Signostics Pty LtdSignostics Pty Ltd – FDA Inspection, Apr 13, 2012
Record Details
This FDA Inspection record concerns Signostics Pty Ltd, with an inspection on April 13, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Signostics Pty Ltd
- Inspection Date
- April 13, 2012
- Product Type
- Devices
View Company Profile
ID · e8f18a09-2f6c-4ba3-8da5-68a95ea9730c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 779921
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - 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
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.