FDA 483 - SP Surgical Products - May 08, 2019

An FDA inspection of St Surgical Products in Caguas, PR, a human tissue establishment, revealed a significant issue with the recording and maintenance of storage temperatures for human tissue products. Specifically, the firm failed to monitor and record temperatures for musculoskeletal human tissue products over an extended period. This critical lapse is a recurrent observation, indicating a persistent non-compliance issue.