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BioMerieux Warned Over CAPA, Rework Procedures

The FDA has warned BioMerieux for several violations related to rework procedures and corrective and preventive actions (CAPA) for its microbial detection systems. The Durham, N.C., facility failed to implement adequate CAPAs after at least 25 nonconformances for BacT/ALERT production lots, according to the Aug. 23 warning letter posted recently online. The FDA supports the company’s post-inspection proposal for additional in-process specifications, but agency verification of these improvements is necessary, the letter states.
Devices & Diagnostics Letter