# FDA 483 - Caribbean Dental Products Corp. - March 04, 2021

Source: https://www.keypedia.com/records/483/caribbean-dental-products-corp/39950b63-52d1-43b0-a116-51de85895aad

> FDA 483 for Caribbean Dental Products Corp. on March 04, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Caribbean Dental Products Corp.
- Inspection Date: 2021-03-04
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Caribbean Dental Products Corp. in Bayamon, PR, a human tissue distributor, revealed a significant lapse in quality control. The firm failed to record and maintain storage temperatures for musculoskeletal human tissue products (HCT/Ps) over extended periods in 2019 and 2020. This indicates a potential risk to product integrity and patient safety.

## Related Officers

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

Company: https://www.keypedia.com/companies/caribbean-dental-products-corp/6e86c4bd-3629-4637-a785-1b27050bc471

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