GO MEDICAL INDUSTRIES PTY. LTD. — FDA Facility Profile
GO MEDICAL INDUSTRIES PTY. LTD. is an FDA-registered facility (FEI 3002807099) located in SUBIACO Western Australia, AU. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Dec 10, 2024: No Action Indicated (NAI)
- Inspections on record
- 4 (1 OAI, 2 VAI, 1 NAI)
- Last OAI inspection
- Sep 14, 2011
- Warning letters
- 1 listed by FDA for this FEI, latest Dec 23, 2011
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 10, 2024 | No Action Indicated (NAI) | No citations listed |
| Jun 21, 2017 | Voluntary Action Indicated (VAI) | Production processes (21 CFR 820.70(a)) Individual Report of Malfunction (21 CFR 803.50(a)(2)) |
| Feb 18, 2015 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 14, 2011 | Official Action Indicated (OAI) | Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i)) Lack/Inad procedure-Monitoring/Control of Validated Proces (21 CFR 820.75(b)) Lack of or inadequate procedures (21 CFR 820.100(a)) Production processes (21 CFR 820.70(a)) and 2 more |
Facility details
- Company
- Go Medical Industries Pty., Ltd.
- Location
- SUBIACO Western Australia (AU)
- Source
- device