FDA EIR - ACM Global Laboratory - December 07, 2017

An FDA inspection of ACM Global Laboratory in Rochester, NY, was conducted from November 27 to December 7, 2017. This high-priority inspection, under the Bioresearch Monitoring Compliance Program and Bio-similar User-Fee Act (BsUFA), aimed to evaluate the central laboratory's role in a clinical study for an anti-neoplastic drug and assess the integrity of its data.The inspection identified significant deficiencies related to the pathological complete response (pCR) analysis. ACM Global Laboratory lacked established written procedures and standard operating procedures (SOPs) for pCR reviews at the study's outset, with formal processes and updated charters introduced well after sample analysis began. A major issue involved the pathology laboratory embedding clinical trial work within routine operations, creating a conflict of responsibility where the lab director also oversaw clinical trials. An internal audit revealed multiple instances of missed discordances, incorrect data recording, irregular changes violating Good Clinical Practice, and pressure on subordinates to alter results to avoid further reviews, leading to potential un-blinding.ACM Global Laboratory had already initiated corrective actions prior to the inspection, including re-reading questionable reports and implementing personnel changes, such as hiring external pathologists. While the FDA investigator expressed concerns regarding the management of pCR reviews, lack of documentation, and data inconsistencies, no FDA Form 483 (Inspectional Observations) was issued at the conclusion of the inspection. The Establishment Inspection Report will be forwarded to the Center for Drug Evaluation and Research (CDER) for final classification.