483
Caldic USA IncFDA 483 - Caldic USA Inc - December 19, 2019
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An FDA inspection of Avatar Corporation in University Park, IL, an API manufacturer, from December 17-19, 2019, revealed one observation. The firm's Quality Unit failed to exercise strict controls over labeling issuance and reconciliation, leading to discrepancies in label counts for a production batch that went undetected during review and approval.
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