CGMP Issues Found at International Medication Systems

A 12/9-12/19/2025 FDA inspection at the International Medication Systems drug manufacturing facility in South El Monte, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/2 Warning Letter says the specific violations were:

• failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
• failure to perform operations within specifically defined areas of adequate size and to have separate or defined areas for such other control systems necessary to prevent contamination or mix-ups to aseptic processing areas, and failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes; and
• failure to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use, and for its cleaning and maintenance.

The letter acknowledges that following a teleconference with agency officials, the company recalled on 4/1 a specific lot of epinephrine injection USP 0.1 mg/mL from the U.S. market due to a lack of sterility assurance.

FDA says significant inspection findings demonstrate that International Medication Systems does not operate an effective quality system in accordance with CGMPs. “In addition to the lack of effective management oversight of your production operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities,” the letter says. “Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.”

FDA recommends that the firm retain a qualified third-party consultant to perform a comprehensive six-system audit of its entire operation for CGMP compliance, assist it in meeting CGMP requirements, and evaluate the completion and efficacy of its corrective and preventive actions before International pursues resolution of its compliance status with the agency.

International was told to address the violations promptly and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.