SURGENEX LLCMarch 29, 2023

FDA 483 - SURGENEX LLC - March 29, 2023

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Record Details

An FDA inspection of SURGENEX LLC in Scottsdale, AZ, from March 22-29, 2023, revealed a significant issue with quality control. The firm failed to adequately control in-process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and did not ensure sterilization validation requirements were met before product release. This included a failure to process dose audit samples and a delay in opening a deviation report.

Company: SURGENEX LLC
Inspection Date: March 29, 2023
Product Type: Biologics
Office: Division of Pharmaceutical Quality Operations IV
People: Kaarin M. Slotte (investigator)
Garrad R. Poole

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ID · ef3ad5e9-43d0-4898-9884-ea211280ab1c