FDA 483 - International Medication Systems Ltd. - May 25, 2022

International Medication Systems Ltd. in South El Monte, CA, a manufacturer of sterile combination drugs and nonsterile API, was cited for a significant quality control issue. The inspection revealed that deviations from written production and process control procedures were not recorded and justified. This included an unrecorded set point increase during the manufacturing of stoppers, which were subsequently used in a distributed drug product.