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FDA Inspection
•Surgical Theater Inc•February 23, 2017

Surgical Theater Inc – FDA Inspection, Feb 23, 2017

Record Details

This FDA Inspection record concerns Surgical Theater Inc, with an inspection on February 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company
Surgical Theater Inc
Inspection Date
February 23, 2017
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Laureen M. Geniusz (FDA Associated Person)
View Company Profile

ID · 7888cdd6-d6f7-45b7-b312-df46701f65e8

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1001888
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Surgical Theater Inc

4
DateClassificationOfficeProject area
June 11, 2026NAICincinnati District OfficePostmarket Assurance: Devices
March 3, 2023VAICenter for Devices and Radiological HealthCompliance: Devices
February 7, 2019NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
March 31, 2014NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Surgical Theater Inc
  • FDA Inspection 1321540 - 2026-06-11
  • FDA Inspection 1198942 - 2023-03-03
  • FDA Inspection 1082795 - 2019-02-07
  • FDA Inspection 871792 - 2014-03-31

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