FDA 483 - Shertech Pharmacy - July 02, 2019

Shertech Pharmacy in Easley, SC, a producer of sterile drug products, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight critical failures in aseptic processing, environmental controls, product testing, and record-keeping, indicating a lack of adequate controls to ensure the sterility, quality, and purity of their drug products. These issues include using non-sterile gloves, inadequate cleanroom maintenance, poor facility design, lack of environmental monitoring, insufficient process validation, and failure to test finished sterile products for sterility and potency.