483
One Surgical Inc.FDA 483 - One Surgical Inc. - October 21, 2021
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Record Details
One Surgical, Inc., a repacker/relabeler in Memphis, TN, received a Form FDA 483 with two observations during an inspection. The firm failed to adequately document corrective and preventive action activities, specifically investigations, root causes, and plan execution. Additionally, complaint files were not properly maintained, with several closed complaints lacking documentation of investigations.
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