# FDA 483 - Surgical Theater Inc - June 11, 2026

Source: https://www.keypedia.com/records/483/surgical-theater-inc/4245c796-201a-450e-8f63-949f92c935a7

> FDA 483 for Surgical Theater Inc on June 11, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Surgical Theater Inc
- Inspection Date: 2026-06-11
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Surgical Theater Inc, a medical device manufacturer in Beachwood, OH, received a Form FDA-483 with three observations during an inspection. The firm was cited for deficiencies in its quality management system, specifically regarding the inadequate incorporation of post-market data into risk management, insufficient document and change control procedures, and poor documentation of design and development reviews. These issues highlight a need for improved adherence to and establishment of robust quality system processes.

## Related Documents

- [483 - 2023-03-03](https://www.keypedia.com/records/483/surgical-theater-inc/fd314c52-41d9-4687-9f0c-acb19866174a)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)

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