FDA Inspection 1321540 — Surgical Theater Inc
The FDA completed an inspection of Surgical Theater Inc on June 11, 2026 in Beachwood, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 11, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Beachwood, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23039 | ISO 13485:2016 Clause 4.2.4 | Document Control Procedure Inadequate |
| 23113 | ISO 13485:2016 Clause 7.3.5 | Records of design and development reviews not maintained |