FDAnews Device Daily Bulletin

St. Jude 483 Calls Out Supplier CAPA Timelines

Aug. 7, 2013
St. Jude’s Arecibo, Puerto Rico, facility has fielded a Form 483 because standard operating procedures did not set a deadline for suppliers responding to or completing corrective actions related to supplier corrective action requests. Under the procedure, suppliers may seek extensions for investigations that are still in process. The procedure does not limit the number of extensions a supplier may request, the May 7 Form 483 says.
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