FDA Inspection 1049811 — Innovative Surgical Designs, Inc.
The FDA completed an inspection of Innovative Surgical Designs, Inc. on April 26, 2018 in Bloomington, IN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 26, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bloomington, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3224 | 21 CFR 820.70(g)(2) | Periodic equipment inspection lack of or inadequate procedu |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |