FDA 483 - SOFTAP INC - December 11, 2023

An FDA inspection of SOFTAP INC, a relabeler in Livermore, CA, revealed seven significant observations concerning its quality system and manufacturing controls. The firm lacked essential written procedures for quality unit responsibilities, product distribution, complaint handling, and employee training, indicating a severe absence of cGMP compliance. These deficiencies raise serious concerns about the quality, safety, and traceability of the drug products Minnerva II and Blockaid that the firm relabels and distributes.