FDA Inspection
Surgical Theater IncSurgical Theater Inc – FDA Inspection, Jun 11, 2026
Record Details
This FDA Inspection record concerns Surgical Theater Inc, with an inspection on June 11, 2026, issued by the Cincinnati District Office, covering medical devices & rad health.
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ID · dc7d679f-9af9-404c-a28a-f86a713cb08a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1321540
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 4.2.4Document Control Procedure Inadequate
- ISO 13485:2016 Clause 7.3.5Records of design and development reviews not maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Surgical Theater Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 3, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 7, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 23, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 31, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Surgical Theater Inc
- FDA Inspection 1198942 - 2023-03-03
- FDA Inspection 1082795 - 2019-02-07
- FDA Inspection 1001888 - 2017-02-23
- FDA Inspection 871792 - 2014-03-31
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