483
Cirtec Medical CorpCirtec Medical Corp – FDA 483, Jan 13, 2026
Record Details
Cirtec Medical Corp. in Brooklyn Park, MN, a medical device manufacturer, received a Form FDA 483 following an inspection from January 7-13, 2026. The inspection revealed deficiencies in process validation, specifically concerning inadequate documentation of training for personnel involved in laser weld protocols. This indicates a moderate severity issue related to quality system controls.
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ID · cdb1fdcd-62ad-4726-b310-749a961e5cff
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