# FDA 483 - Surgical Theater Inc - March 03, 2023

Source: https://www.keypedia.com/records/483/surgical-theater-inc/fd314c52-41d9-4687-9f0c-acb19866174a

> FDA 483 for Surgical Theater Inc on March 03, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Surgical Theater Inc
- Inspection Date: 2023-03-03
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Surgical Theater Inc. in Beechwood, OH, revealed multiple quality system deficiencies. The firm failed to adequately document rework activities, maintain complete design history files for its Class II spinal surgical navigation device, and conduct required quality audits and management reviews. These observations indicate a lack of adherence to established quality control procedures.

## Related Officers

- [Talmane J. Fisher](https://www.keypedia.com/people/talmane-j-fisher/f69c101f-fbc7-4ca1-a6d1-1e25450c52b7)

Company: https://www.keypedia.com/companies/surgical-theater-inc/991a3840-ccc7-40d8-a183-ebd1b691725a

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22