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Molteno Ophthalmic Limited

FDA Regulatory Profile

Molteno Ophthalmic Limited has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 2 compliance actions on record.

What these totals cover: FDA records filed under the name "Molteno Ophthalmic Limited".

Latest inspection: Dec 18, 2024 · NAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	5	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	2	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Molteno Ophthalmic Limited's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	1	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

5 inspections from Dec 2, 2009 to Dec 18, 2024.

Date	Site	Product	Classification	FEI
Dec 18, 2024	Dunedin, New Zealand	Devices	No Action Indicated (NAI)	3001227772
Nov 14, 2019	Dunedin, New Zealand	Devices	Voluntary Action Indicated (VAI)	3001227772
Oct 30, 2014	Dunedin, New Zealand	Devices	No Action Indicated (NAI)	3001227772
Apr 21, 2011	Dunedin, New Zealand	Devices	Voluntary Action Indicated (VAI)	3001227772
Dec 2, 2009	Dunedin, New Zealand	Devices	Official Action Indicated (OAI)	3001227772

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 2 compliance actions under Molteno Ophthalmic Limited: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Feb 27, 2015.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3001227772	Dunedin, New Zealand	5	Dec 18, 2024

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