483
SterisSteris – FDA 483, May 24, 2022
Record Details
Zutron Medical LLC in Lenexa, KS, was inspected by the FDA from May 20-24, 2022. The inspection resulted in one observation concerning the firm's failure to adequately establish procedures for controlling and documenting non-conforming medical products. This indicates a lapse in their quality system regarding product control and record-keeping.
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ID · 1ccc72b3-6253-483d-81bc-08c11bf16ce4
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