Menicon Singapore Pte Ltd FDA Record
Menicon Singapore Pte Ltd has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Menicon Singapore Pte Ltd" is on file.
- Latest inspection
- Jan 15, 2025 · NAI
Summary
| 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 | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 15, 2025 | Singapore, Singapore | Devices | No Action Indicated (NAI) | 3009104180 |
| Sep 1, 2022 | Singapore, Singapore | Devices | Voluntary Action Indicated (VAI) | 3009104180 |
| Dec 15, 2015 | Singapore, Singapore | Devices | Voluntary Action Indicated (VAI) | 3009104180 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3009104180 | Singapore, Singapore | 3 | Jan 15, 2025 |
Menicon Singapore Pte Ltd and the FDA: common questions
Has Menicon Singapore Pte Ltd received an FDA warning letter?
No FDA warning letter addressed to the name "Menicon Singapore Pte Ltd" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Menicon Singapore Pte Ltd received an FDA Form 483?
FDA has not published a Form 483 for "Menicon Singapore Pte Ltd" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Menicon Singapore Pte Ltd?
The most recent FDA inspection on file ended Jan 15, 2025 at Singapore, Singapore and was classified NAI. FDA has 3 inspections of Menicon Singapore Pte Ltd on file.
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