Topcon Healthcare, Inc. FDA Inspection Record
Topcon Healthcare, Inc. is an FDA-registered facility (FEI 2242863) located in Oakland, NJ, US. RegDataLab tracks 3 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Mar 14, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (2 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 3, latest Sep 17, 2024
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 14, 2025 | Voluntary Action Indicated (VAI) | Quality audits - auditor independence (21 CFR 820.22) Design validation- Lack of or inadequate procedures (21 CFR 820.30(g)) Lack of or inadequate procedures (21 CFR 820.100(a)) Complaints (21 CFR 820.198(a)) and 3 more |
| Jan 20, 2015 | No Action Indicated (NAI) | No citations listed |
| Jun 16, 2014 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures (21 CFR 820.100(a)) Investigation of device failures (21 CFR 820.198(c)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Sep 17, 2024 | Class II | Z-0362-2025 | The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in… The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not… |
| Dec 18, 2020 | Class II | Z-0952-2021 | Harmony Referral System (aka Harmony RS)/ Medical Device
Data System - Product Usage… Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of non-unique patient IDs that caused… |
| Mar 6, 2019 | Class II | Z-1138-2019 | IMAGEnet 6 v1.53-
IMAGEnet 6 Ophthalmic Data System is a software program that is… When a patient is selected in the patient data and another patient is selected prior to the display of the primary patient's thumbnails is… |
FDA record score
10 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
5 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Mar 14, 2025 | 6 x 1 | 6 |
| Class II recall Z-0362-2025, this FEI as the recalling firm | Sep 17, 2024 | 4 x 0.6 | 2.4 |
| Class II recall Z-0952-2021, this FEI as the recalling firm | Dec 18, 2020 | 4 x 0.25 | 1 |
| Class II recall Z-1138-2019, this FEI as the recalling firm | Mar 6, 2019 | 4 x 0.25 | 1 |
| Inspection classified VAI | Jun 16, 2014 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- Topcon Medical Systems, Inc.
- Location
- Oakland, NJ (US)
- Source
- device