FDA Observes Tennessee Devicemaker for Stability Studies

January 14, 2021

The FDA has observed inadequate design verifications and root cause analyses for nonconforming products during an inspection of Nashville, Tennessee’s MRP, a hypodermic needle and syringe maker.

One product evaluated in a stability study to support a 24-month shelf life was not sterilized using challenge sterilization conditions and sample sizes used in the study weren’t based on a valid statistical rationale, the agency observed in findings in a Form 483.

Corrective and preventive actions were also found to be inadequate because they didn’t ensure that the root cause of nonconformances was identified during investigations, the Form 483 said.

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