Prosec Protection Systems, a maker of umbilical clamps, received a Form 483 for various process validation deviations at its Lakewood, N.J., plant.
Prosec, also known as McRoberts Security Technologies, does not test its clamps for assurance of stability, nor does it accurately interpret, document or review its sterility testing procedures prior to shipment, the form states.
Sterility cycle reports are supposed to be reviewed and approved, but numerous cycles passed in 2011 without such reviews or approvals, FDA investigators said.
Lakewood staff also broke from company protocol on sterilization validation runs. For example, a final validation report for an interim run that failed for “temperature out of range” provided no rationale for not running consecutive cycles. The failure also was not investigated or evaluated, according to the form.
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