FDA Inspection 871792 — Surgical Theater Inc
The FDA completed an inspection of Surgical Theater Inc on March 31, 2014 in Beachwood, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 31, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Beachwood, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |