FDA 483 - Option Care Enterprises, Inc. dba Option Care - March 12, 2019

During an inspection conducted from March 5-12, 2019, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Option Care Enterprises Inc., operating as Option Care, located in Little Rock, AR. The firm, a producer of sterile drugs, received observations highlighting significant deficiencies in its aseptic processing operations.The FDA investigator noted three primary issues. Firstly, materials and supplies were not properly disinfected before being introduced into aseptic processing areas, as observed when operators placed items into ISO 5 hoods without prior sterile wiping during the production of critical medications. Secondly, the facility's design permitted the influx of lower-quality air into higher-classified aseptic areas. This was evidenced by doors to both non-classified and ISO 7 ante rooms opening simultaneously, compromising environmental control during sterile drug production. Lastly, the company's media fill simulations, which are crucial for validating aseptic processes, were not representative of worst-case conditions or the maximum batch sizes used in their aseptic operations. For instance, media fills did not adequately simulate the largest syringe and IV bag batch sizes produced. These observations indicate potential non-compliance with current Good Manufacturing Practices (GMP) for sterile drug production. Option Care is required to address these deficiencies by implementing effective corrective actions to ensure the sterility and quality of its drug products.