FDA 483 - Calyxo, Inc. - March 04, 2022

Calyxo, Inc. in Pleasanton, CA was inspected from February 28 to March 4, 2022, and received a Form FDA 483 with two observations. The inspection revealed inadequate procedures for the control and distribution of finished devices, including issues with shelf life updates and bioburden monitoring. Additionally, the firm failed to adequately establish and implement procedures for monitoring and controlling validated process parameters.