Medical Kit Maker Gets Warning for Composite-Sample Testing
The company failed to demonstrate that, after aeration, its convenience kits exposed to ethylene oxide (EtO) sterilization and re-sterilization cycles rendered acceptable residual levels of EtO and ethylene chlorohydrins before distributing them, according to the Sept. 11 letter posted recently on the FDA website.
Customed — which makes nursing kits, baby care kits, and surgical trays and packs — reported residual limit results
as a composite of samples of devices within the kits, FDA investigators found during a March 31 through May 13 inspection.
The GMP Letter