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FDAnews Device Daily Bulletin
June 25, 2012 | Vol. 9 No. 124
Prosec Protection Systems Handed 483 for Process Validation Lapses
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.
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