Home » Medical Kit Maker Gets Warning for Composite-Sample Testing
Medical Kit Maker Gets Warning for Composite-Sample Testing
Composite-sampling problems at Customed’s
Puerto Rico plant led to a warning letter for
the maker of medical convenience kits.
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
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