FDA 483 - Legacy Pharmaceutical Packaging LLC - June 20, 2023
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Legacy Pharmaceutical Packaging LLC, a medical device repacker/relabeler in Earth City, MO, was cited for two significant issues during an FDA inspection. The firm failed to establish adequate procedures for corrective and preventive actions, as evidenced by an ineffective action item related to missing medical device components. Additionally, the inspection found that software used in the quality system, specifically for labeling with QR codes, had not been adequately validated for its intended use since 2011.
ID · 1e6d340f-d04a-41c7-b635-6e03d603e170