FDA EIR - ICON Laboratory Services, Inc. - June 26, 2015

An FDA Establishment Inspection Report details findings from an inspection of ICON Laboratory Services in Whitesboro, NY, conducted from June 22 to June 26, 2015. The inspection team, comprising a Lead FDA Investigator and a CDER-OSIS Pharmacologist, focused on the company's bioanalytical laboratory services. At the conclusion of the five-day assessment, a single inspectional observation was noted and documented in a Form FDA 483, which was issued to Dr. Paula M. Jardieu, Senior Vice President and General Manager. Although the specific details of this observation are not provided within this document, the issuance of an FDA 483 indicates that the investigators identified a condition or practice that may constitute a violation of the Federal Food, Drug, and Cosmetic Act or related acts. Under the regulatory framework governing such laboratories, ICON Laboratory Services is required to formally respond to the FDA, outlining comprehensive corrective and preventive actions to address the identified deficiency and ensure full adherence to applicable good laboratory practices and quality system regulations for its bioanalytical operations.