Devicemakers Cited for Lack of Validation, Quality Procedures

Two companies registered with the FDA as a single establishment with jointly listed devices lacked procedures for verifying and validating their finished devices, according to a warning letter. The FDA cited RespCare and InnoMed Technologies, which manufacture continuous positive airway pressure interface devices for respiratory problems and sleep apnea, for not ensuring their corrective and preventive action procedures do not adversely affect their finished devices.
The GMP Letter