MOLTENO OPHTHALMIC LTD. — FDA Facility Profile
MOLTENO OPHTHALMIC LTD. is an FDA-registered facility (FEI 3001227772) located in DUNEDIN Otago, NZ. RegDataLab tracks 5 FDA inspections and 2 compliance actions at this facility.
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What FDA found at this site
- Latest inspection
- Dec 18, 2024: No Action Indicated (NAI)
- Inspections on record
- 5 (1 OAI, 2 VAI, 2 NAI)
- Last OAI inspection
- Dec 2, 2009
- Warning letters
- 2 listed by FDA for this FEI, latest Feb 27, 2015
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 18, 2024 | No Action Indicated (NAI) | No citations listed |
| Nov 14, 2019 | Voluntary Action Indicated (VAI) | No citations listed |
| Oct 30, 2014 | No Action Indicated (NAI) | Quality audits - Lack of or inadequate procedures (21 CFR 820.22) Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i)) |
| Apr 21, 2011 | Voluntary Action Indicated (VAI) | No citations listed |
| Dec 2, 2009 | Official Action Indicated (OAI) | No citations listed |
Facility details
- Company
- Molteno Ophthalmic Limited
- Location
- DUNEDIN Otago (NZ)
- Source
- device