Eight Observations in Fusion IV FDA-483

FDA has released the FDA-483 issued following its 3/3-3/23 inspection at Fusion IV Pharmaceuticals, Los Angeles, CA, a producer of sterile drug products. Observations were: 

•          failing to establish procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
• ·       failing to have procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the sterilization process;
•          failing to sterilize and process drug product containers and closures to remove pyrogenic properties to assure they are suitable for their intended use;
• ·        deficiency in aseptic processing areas regarding the system for monitoring environmental conditions;
•          failing to test through appropriate laboratory testing each batch of drug product required to be free of objectionable microorganisms;
•          deficient labels of the outsourcing facility’s drug products;
•          failing to exercise strict control over labeling issued for use in drug product labeling operations; and
•          failing to submit to FDA an outsourcing facility initial report identifying products compounded during the previous six months.