FDA EIR - SAFC Carlsbad Inc. - September 12, 2019

An FDA inspection of SAFC Carlsbad, Inc., operating as MilliporeSigma, a contract manufacturer of biological drug substance, was conducted from September 4 to September 12, 2019. This comprehensive Good Manufacturing Practice (GMP) inspection, performed under Compliance Program 7345.848, evaluated the Quality, Production, Facilities & Equipment, Materials, Laboratory, and Packaging & Labeling systems. The inspection resulted in the issuance of a FORM FDA 483, detailing eight objectionable conditions. Key issues included deficiencies in environmental monitoring within aseptic processing areas, inadequate security for label templates and un-dispositioned labels, and a repeat observation regarding insufficient periodic validation of supplier certificates of analysis for specific materials. Other violations cited involved an unqualified Biological Safety Cabinet under dynamic conditions, lack of visual inspection for certain components, unproven qualification for microbial ingress prevention in processing systems, sub-optimal incubation conditions for environmental monitoring samples, and insufficient functional training for complex operations. Although the firm had partially corrected one observation from a prior 2017 pre-license inspection, these new findings indicate that SAFC Carlsbad, Inc. is required to implement corrective actions to address the identified deficiencies and ensure ongoing compliance with regulatory standards for biological drug substance manufacturing.