FDA 483 - Med Shop Total Care Inc. - November 01, 2018

The FDA Form 483 details numerous deficiencies at a facility manufacturing sterile and non-sterile drug products, including veterinary and human intrathecal products.

**Environmental Monitoring & Aseptic Processing:** * Aseptic processing areas lack adequate environmental monitoring systems. * Microorganisms from environmental and fingertip monitoring were not identified, and production continued without complete investigations or corrective actions. * Procedures for environmental monitoring are deficient, lacking microorganism impact assessment and specific sampling locations. * Only viable and non-viable particulates are monitored, and a qualified individual for plate reading is absent. * Media fills do not simulate worst-case conditions, omitting smallest/largest batch sizes and different container types. * Smoke studies under dynamic conditions in ISO 5 areas are not performed, with the observed study only demonstrating pulling drug product from a vial into a syringe.

**Product Testing & Quality Control:** * Sterile drug products are not tested for objectionable microorganisms or pyrogens. * Endotoxin analysis is absent for sterile veterinary stock solutions, and the human sterile stock solution endotoxin test method is non-compendial. * No endotoxin testing is conducted for finished sterile drug products, including intrathecal products containing Morphine Sulfate, Bupivacaine, Fentanyl, Clonidine, Baclofen, or Hydromorphone. * Finished product release testing does not include identity and strength determination for active ingredients. * Testing results for veterinary products are not documented.