FDA EIR - Daniel Gruener - September 04, 2014

An FDA inspection of Clinical Investigator Dr. Daniel Gruener, affiliated with PRA Health Sciences in Philadelphia, PA, occurred from August 27 to September 4, 2014. Conducted under Compliance Program 7348.811 for Clinical Investigators, this pre-approval New Drug Application (NDA) inspection reviewed a clinical study for Paliperidone Palmitate. Notably, no FDA Form 483 was issued; instead, several key discussion items were addressed. These included missing final disposition documentation for one investigational drug kit, although others were reconciled. Additionally, minor discrepancies were identified between source documents and assignment line listings for symptom severity scores, though these did not affect total scores. A third concern involved incomplete adherence to temperature monitoring device instructions for investigational drug shipments, specifically regarding the attachment of monitor stickers to documentation sheets for a period. Dr. Gruener and PRA Health Sciences management acknowledged these findings and committed to implementing corrective actions for future studies. Recommendations focused on expediting SOP revisions for investigational product handling, enhancing staff training for data accuracy, and reinforcing meticulous documentation for temperature-controlled shipments to ensure regulatory compliance and product integrity.