483
Grafton Medical AllianceGrafton Medical Alliance – FDA 483, Aug 4, 2021
Record Details
Grafton Medical Alliance, a repacker/relabeler in Burr Ridge, IL, was cited with two observations during an FDA inspection. The firm failed to maintain complaint files, specifically regarding the proper documentation of "screwdriver stripped" complaints. Additionally, the quality policy was not properly established by management, lacking required signatures from the CEO and COO.
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ID · 129fe8a4-aaa4-4275-9bd5-0f327136389a
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