483
SterisFDA 483 - Steris - May 24, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
Open in Dashboard
ID · 1ccc72b3-6253-483d-81bc-08c11bf16ce4