FDA 483 - Ortho & Surgical Solutions, Inc. - November 22, 2019

Ortho & Surgical Solutions, Inc. in Guaynabo, PR, was inspected by the FDA from November 18-22, 2019. The inspection revealed a recurrent observation regarding inadequate record-keeping practices. Specifically, the firm failed to document the person delivering human tissue products to surgical sites and the dates of these entries in their distribution records.