www.fdanews.com/articles/114183-devicemakers-cited-for-lack-of-validation-quality-procedures
Devicemakers Cited for Lack of Validation, Quality Procedures
January 30, 2009
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 (CPAP) interface devices for treating respiratory problems and sleep apnea, for not ensuring their corrective and preventive action procedures do not adversely affect their finished devices, the letter says.
During an inspection of the companies’ Coconut Creek, Fla., plants, an FDA investigator examined several complaints alleging that RespCare and InnoMed’s hybrid CPAP products had valves misassembled at their contract manufacturer in Taiwan.
The GMP Letter
The FDA cited RespCare and InnoMed Technologies, which manufacture continuous positive airway pressure (CPAP) interface devices for treating respiratory problems and sleep apnea, for not ensuring their corrective and preventive action procedures do not adversely affect their finished devices, the letter says.
During an inspection of the companies’ Coconut Creek, Fla., plants, an FDA investigator examined several complaints alleging that RespCare and InnoMed’s hybrid CPAP products had valves misassembled at their contract manufacturer in Taiwan.
The GMP Letter