483
FUJIFILM Healthcare Americas CorporationFUJIFILM Healthcare Americas Corporation – FDA 483, Jul 2, 2019
Record Details
Fujifilm Medical Systems U.S.A., Inc. in Wayne, NJ, was inspected regarding its complaint file establishment. The inspection revealed deficiencies in the firm's complaint handling procedures, specifically regarding the closure of complaint investigations and the documentation of decisions not to report potential Medical Device Reports (MDRs). These issues indicate a lack of adherence to established internal procedures for record-keeping and decision deliberation.
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ID · 66a3154e-a133-43af-b37d-f36733e1a0e8
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