FDA EIR - ICON Laboratory Services, Inc. - August 30, 2018

During an FDA Good Laboratory Practice (GLP) inspection of ICON Laboratory Services, Inc. in Whitesboro, NY, conducted from August 27-30, 2018, a verbal observation was made regarding the firm's Master Schedule. This inspection, performed under the Bioresearch Monitoring Compliance Program and GLP regulations (21 CFR Part 58), aimed to assess compliance with standards for nonclinical laboratory studies. The primary issues identified were that the Master Schedule improperly listed two 'in-process' studies without identified initiation dates or designated Study Directors. Furthermore, two non-GLP studies were inappropriately included on the GLP Master Schedule. It is noteworthy that a prior 2015 inspection had also identified master schedule completeness issues. ICON Laboratory Services, Inc. promptly addressed these findings by voluntarily correcting the Master Schedule deficiencies during the inspection itself. Consequently, due to these immediate corrective actions, no official FDA Form 483, Inspectional Observations, was issued at the conclusion of the inspection, indicating a satisfactory resolution of the identified observations.