FDA 483 - Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy - August 11, 2022

An FDA inspection of Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy in Fort Myers, FL, a producer of sterile and non-sterile products, revealed two significant observations. The firm failed to adequately evaluate products and take remedial action following microbial contamination in a cleanroom area. Additionally, the sterilization process for intrathecal products was found to be inadequate, specifically concerning sterility testing.