FDA 483 - Med-Pharmex, Inc. - December 18, 2023

Med-Pharmex, Inc. in Pomona, CA, was inspected and cited for significant deficiencies in its manufacturing processes and quality control. Observations included inadequate production and process controls, unvalidated test methods, undocumented production procedures, and improper handling of drug product components, leading to product quality issues and numerous customer complaints, including adverse drug events. The inspection revealed repeat observations, indicating persistent issues.