# FDA 483 - SP Surgical Products - May 08, 2019

Source: https://www.keypedia.com/records/483/sp-surgical-products/efcd7458-3784-4522-992f-89339130976e

> FDA 483 for SP Surgical Products on May 08, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SP Surgical Products
- Inspection Date: 2019-05-08
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: 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.

## Related Officers

- [Annette Melendez](https://www.keypedia.com/people/annette-melendez/bc1a065d-6408-4c4b-9dcf-c6884e8a75c4)

Company: https://www.keypedia.com/companies/sp-surgical-products/3b3373b7-6e5e-48fa-b6c5-7e8ec24739ab

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6