ICON Laboratory Services, Inc. – FDA EIR, Jan 29, 2015

An FDA bioanalytical inspection of ICON Development Solutions in Whitesboro, NY, occurred from January 21-29, 2015. Conducted under Compliance Program 7348.001 for biosimilar studies (PHSA 351(k)), the inspection covered analytical data for a specific BLA submission. Although no Form FDA-483 (Inspectional Observations) was issued, several significant findings were discussed with company management.Key issues included inconsistent documentation practices, such as sloppy handwritten sample box labels and a discrepancy between the study report and actual electronic receipt of sample demographics. Critically, long-term frozen stability data covering the full sample storage duration was not available during the inspection. Instances were found where lab/method errors in reports lacked corresponding documentation in laboratory notebooks. In method validation, there were concerns regarding inconsistent inter-run statistics, reprocessed data not fully noted or accompanied by original records, and the exclusion of precision values from calculations. The firm also lacked established criteria for re-analyzing individual negative controls during cut point determination and accepted control samples in several instances despite failing duplicate well variance criteria, deviating from their own validation plan.ICON Development Solutions committed to submitting the missing stability data, correcting reporting inaccuracies, improving error documentation, and establishing more consistent data acceptance and re-analysis criteria for future studies.