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