483
Surgical Theater IncFDA 483 - Surgical Theater Inc - March 03, 2023
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Record Details
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.
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