FDA Inspection 1198942 — Surgical Theater Inc
The FDA completed an inspection of Surgical Theater Inc on March 3, 2023 in Beachwood, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 3, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Beachwood, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3841 | 21 CFR 820.90(b)(2) | Product rework adverse effects {see also 820.184} |
| 4061 | 21 CFR 820.20(b)(3)(ii) | Management representative's reports |