In response to an FDA warning letter request, a multinational pharmaceutical company selected Greenleaf Health as an independent third-party expert to perform retrospective assessment of out-of-specification (OOS) investigations and a systemic assessment of systems for investigations.

Greenleaf experts developed a protocol for performing the retrospective review, which established the conclusiveness of OOS investigative results, determined whether the laboratory methods or relevant techniques contributing to conclusive OOS investigative results had been appropriately remediated, and designated inconclusive OOS investigative results as requiring further manufacturing investigations by the company. In conjunction with the retrospective review, Greenleaf conducted a comprehensive assessment of the company’s system for investigating deviations, complaints, and OOS results. This assessment occurred through Greenleaf’s review of written procedures, work instructions, formal training programs, and system-relevant CAPAs. 

Upon completion of the assessment, the Greenleaf team developed a report detailing the evaluation approach, findings, and conclusions. The final report, which was provided to the company and deemed acceptable by the FDA, also included actionable recommendations to achieve FDA and corporate compliance objectives.