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FDAnews Device Daily Bulletin
June 21, 2012 | Vol. 9 No. 122
Faulty CAPA Follow-Through Prompts Form 483 for Aqueduct
A review of several corrective and preventive action (CAPA) forms at Aqueduct Medical’s San Francisco facility revealed inadequate CAPA validation and follow-up, a recent Form 483 states. Aqueduct, a maker of masks and vests for use by patients during recovery from facial and cosmetic surgery, opened several CAPAs in 2010 and 2011 to address defective welds but did not document any follow-up with its contract manufacturers, the Dec. 7, 2011, form states.
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