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Failure to Report Adverse Events Behind California Company’s 483

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Riverside, Calif.-based Pacific Consolidated Industries (PCI) received a nine-count Form 483 after inspectors from the Irvine, Calif., CDRH office found deviations in the company’s complaint and adverse event handling activities. The report followed a Jan. 31 – Feb. 13 inspection of the portable and mobile air separation equipment maker. The inspectors found several cases where five-day MDR reports were not submitted to the FDA in a timely manner. In one instance, a unit exploded; PCI never evaluated the incident or determined whether it needed to be reported as an MDR. Inspectors also took issue with PCI’s complaint handling, noting that information was missing from several files, while others were not investigated or closed in a timely manner.
The GMP Letter