FDA 483 - Alon Medical Technology, LLC - March 31, 2022

Alon Medical Technology, LLC, a tissue distributor in Lafayette, LA, was cited for significant deficiencies in record-keeping during an FDA inspection. Observations included a lack of documentation for incoming human cells, tissues, and cellular and tissue-based products (HCT/Ps) inspections and inconsistent, incomplete, and inaccurate temperature logs for stored tissue products. These issues indicate a failure to maintain adequate control over critical processes and environmental conditions.