SP Surgical ProductsMay 8, 2019

FDA 483 - SP Surgical Products - May 08, 2019

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Record Details

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.

Company: SP Surgical Products
Inspection Date: May 8, 2019
Product Type: Other
Office: Division of Human and Animal Food Operations - East IV
Person: Annette Melendez

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ID · efcd7458-3784-4522-992f-89339130976e