FDA Observes Tennessee Devicemaker for Stability Studies

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.