FDA 483 - AGC Biologics, Inc.

ICMC Biologics, Inc, dba AGC Biologics in Bothell, WA, received a Form 483 with four observations following an FDA inspection from October 4-15, 2018. The inspection revealed significant deficiencies in contamination control, facility maintenance, corrective action procedures, and electronic record integrity. These issues indicate a lack of robust quality systems and controls in critical manufacturing and data management areas.