FDA 483 - INDUCTION THERAPIES LLC - June 29, 2021

INDUCTION THERAPIES LLC received a Form FDA 483 with three observations related to its quality system. The firm failed to adequately establish and implement procedures for complaint handling and investigation, including specific instances of unvalidated processes and unperformed investigations. Additionally, the firm did not define adequate criteria for determining if a product fails to meet specifications, particularly concerning patient skin injury, and lacked documented and statistically valid sampling methods for acceptance testing of needle cartridges.