FDA 483 - Kimera Labs Inc - July 21, 2022

Kimera Labs Inc. received a Form 483 citing numerous deficiencies in its manufacturing and quality control processes for biological drug products like XoGlo, XoGlo Pro, and Amnio 2X. The observations highlight a critical lack of validation for aseptic processes, cleaning, equipment, and sterility testing, alongside inadequate procedures for environmental monitoring, investigations, and material management. These issues indicate a systemic failure to ensure the identity, strength, quality, and purity of its sterile drug products.