FDA Inspection 1156653 — Opus KSD, Inc.
The FDA completed an inspection of Opus KSD, Inc. on Nov 12, 2021 in Pembroke, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 12, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pembroke, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |