FDA 483 - Predictable Surgical Technologies - November 08, 2023

During an FDA inspection conducted from November 6-8, 2023, at Predictable Surgical Technologies, located at 10130 Toebben Drive, Independence, KY 41051, an observation was made regarding the storage of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm, owned by George F. Rebitski, was inspected as a Human Tissue establishment.

The specific observation noted was that storage temperatures of HCT/Ps were not recorded. This deficiency was further detailed by stating that since the last inspection on November 18, 2021, the firm has not recorded storage temperatures for its room temperature bone products. This finding indicates a lapse in maintaining proper environmental controls and documentation for critical biological products. The inspection was conducted by Investigator Jennifer L. Sheehan, and the Form FDA 483 was issued on November 8, 2023.