483
Implant Direct Sybron Manufacturing LLCImplant Direct Sybron Manufacturing LLC – FDA 483, May 12, 2021
Record Details
Implant Direct Sybron Manufacturing LLC in Thousand Oaks, CA, a medical device manufacturer, was cited for inadequate documentation of corrective and preventive action activities. The firm failed to properly document corrective actions for multiple in-process non-conformances related to labeling and packaging issues, including part mix-ups and missing components. This indicates a significant lapse in their quality system regarding CAPA implementation and record-keeping.
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ID · 4984495c-31c6-418f-b74d-68b508e28ab9
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