Caribbean Dental Products Corp.March 4, 2021

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

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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.

Company: Caribbean Dental Products Corp.
Inspection Date: March 4, 2021
Product Type: Biologics
Office: Division of Human and Animal Food Operations - East IV
Person: Annette Melendez

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ID · 39950b63-52d1-43b0-a116-51de85895aad