FDA EIR - SAFC Carlsbad Inc. - December 16, 2021

SAFC Carlsbad Inc. was the subject of an eight-day FDA inspection conducted from December 7 to December 16, 2021. This Level II Current Good Manufacturing Practice (cGMP) assessment, part of the Division of Biological Products Operations I's FY22 work plan and falling under the Cell Gene Therapy Products profile, focused on the company's role as a contract manufacturer of bulk drug substances for licensed biological products. The inspection led to the issuance of a Form FDA-483, detailing seven significant observations. Key issues included the non-activation of differential pressure alarms in specific production areas, deficiencies in procedures for managing biohazardous waste and conducting product changeovers, and inadequate cleaning protocols to mitigate cross-contamination risks. Additional findings highlighted a lack of identity testing for certain incoming materials, insufficient aseptic process validation for a manufacturing process, environmental monitoring settling plates not meeting predefined acceptance criteria, and inadequate controls for limited access storage of a specific substance. SAFC Carlsbad Inc. is required to provide a written response to the FDA addressing these findings. Prior inspection deficiencies from 2019 were verified as corrected.