FDA EIR - AGC Biologics, Inc. - April 18, 2012

An abbreviated FDA inspection of CMC ICOS Biologics, Inc. in Bothell, WA, was conducted from April 16-18, 2012. The inspection's primary purpose was to gather information, update the company's organizational details and capital improvements, and verify its current FDA-regulated clinical trial materials. This directed inspection was initiated in anticipation of a full licensing inspection for a Biological License Application (BLA) related to an Investigational New Drug (IND) the company's customer had submitted.

CMC ICOS Biologics operates as a contract manufacturing organization, producing active pharmaceutical ingredients (APIs) for Phase I, II, and III human drug clinical trials, specifically CBER-regulated blood-related proteins. The firm had recently registered with the FDA as a drug manufacturer.

Notably, no objectionable conditions or regulatory violations were identified during this abbreviated inspection. Consequently, no Form FDA 483 Inspectional Observations was issued, and no deficiencies were discussed with management. As such, no specific remedial actions were required from the firm as a direct result of this particular inspection. The inspection concluded with a general reminder to management regarding their responsibility for compliance.