FDA Inspection 1334114 — Opus KSD, Inc.
The FDA completed an inspection of Opus KSD, Inc. on Sep 3, 2026 in Pembroke, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 3, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pembroke, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23025 | ISO 13485:2016 Clause 4.1.5 | Control over outsourced processes not proportionate to risk |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |