Home » UltraRad Documentation Failings Lead to Multi-Count 483
UltraRad Documentation Failings Lead to Multi-Count 483
During a recent FDA inspection of UltraRad Corporation, a review of three complaint records found no indication of whether a formal investigation was initiated and, if not, the reason and the name of the decisionmaker. Such information should have been documented as per the company’s complaint handling procedure, according to a March 26 Form 483.
The GMP Letter
The GMP Letter
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