Failure to Report Adverse Events Behind California Company’s 483

Riverside, Calif.-based Pacific Consolidated Industries 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.
The GMP Letter