483
James Alexander Corp.FDA 483 - James Alexander Corp. - February 27, 2019
Record Details
An FDA inspection of James Alexander Corp in Blairstown, NJ, a drug contact manufacturer, revealed significant deficiencies in their quality control unit's written procedures. Specifically, the firm lacked approved procedures for handling deviations and change controls, with existing procedures remaining in draft status for approximately one year. This indicates a critical lapse in maintaining a robust quality system.
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ID · 474497fc-da49-4b7c-ad2e-afce6dc5de89