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.
300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
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