Colorado Devicemaker Warned for Lax Quality Systems
The FDA has issued a warning letter to DeChoker’s Wheat Ridge, Colo., facility for inadequate corrective and preventive action (CAPA) procedures and other quality system failures observed during an inspection in February.
The firm makes the Dechoker tracheobronchial suction device that is intended to remove an obstruction from a choking victim. The devices have been manufactured since May 2019, but the firm had not validated all its manufacturing processes, the agency said.
The firm received 13 complaints for failures of the device that resulted in CAPA procedures, but it failed to properly document the corrective actions, the FDA found.