PPD Development, L.P. – FDA EIR, Sep 21, 2018

An FDA Good Laboratory Practice (GLP) data audit surveillance inspection was conducted at PPD Development, LLC in Richmond, VA, from September 17 to September 21, 2018. The inspection, carried out under the Prescription Drug User Fee Act (PDUFA) and Compliance Program 7348.808, focused on the company's bioanalytical laboratory operations. The purpose was to audit GLP data, protocols, facilities, quality assurance, equipment maintenance and calibration, standard operating procedures, sample handling and storage, employee training records, and record archives.

During the five-day inspection, investigators performed data audits, comparing final reports to source data, and reviewed various operational aspects and quality systems. Notably, no discrepancies were observed in the data audits. The firm demonstrated adherence to its written standard operating procedures for equipment calibration and maintenance, and employee training records were found to be compliant with internal SOPs and position qualifications.

Crucially, at the conclusion of the inspection, no Form FDA 483, which lists inspectional observations or violations, was issued. Furthermore, no objectionable conditions were observed, and no discussion items requiring follow-up action were addressed with management. This indicates that PPD Development, LLC was found to be operating in compliance with the regulatory framework, requiring no specific corrective actions from the company following this surveillance audit.