AGC Biologics, Inc. – FDA EIR, May 15, 2015

An FDA inspection of CMC ICOS Biologics, Inc. in Bothell, WA, was conducted from May 5-15, 2015, under CPGM 7356.002F and 7356.002, focusing on Active Pharmaceutical Ingredient and Drug processes for CBER-regulated biologics to ensure GMP compliance. While no Form FDA 483 was issued, several issues were discussed. These included inadequate humidity controls in the raw materials warehouse and QC sample preparation room, disorganized storage resulting in mixing of released and quarantined materials, and the arbitrary assignment of raw material expiration dates without supporting stability data. Further observations highlighted the lack of defined risk classification scores in raw material assessment, absence of standards/comparators and periodic visual acuity checks for analysts performing visual appearance tests, and insufficient documentation of cleaning for Biological Safety Cabinets. Additionally, certain trend deviations were closed without a probable root cause. In response, CMC ICOS Biologics, Inc. voluntarily committed to and initiated corrective actions, including implementing humidity monitoring and trending, improving warehouse organization, conducting stability studies for raw material shelf-life, updating risk assessment procedures, revising visual appearance test SOPs to include vision checks and comparators, and ensuring proper documentation for BSC cleaning. The firm also agreed to consider performing mycoplasma tests on incoming working cell banks.