FDA WARNING_LETTER - International Medication Systems Ltd. - December 19, 2025

The FDA issued a warning letter to International Medication Systems Limited following an inspection of its California facility from December 9 to 19, 2025. The agency identified several critical violations of Current Good Manufacturing Practice (CGMP) standards, which have rendered the company’s injectable drug products adulterated under the Federal Food, Drug, and Cosmetic Act. Key issues included the company"s failure to thoroughly investigate contamination. Investigators discovered insect larvae and extreme microbial growth in sterile manufacturing zones, yet the company released the affected drug batches after performing inadequate root cause analyses. Furthermore, the facility’s aseptic processing lines were poorly designed, involving high-risk manual interventions that were not properly monitored or validated. The FDA also highlighted significant equipment maintenance failures, such as the discovery of thick biofilms and algae in water storage tanks, which were improperly repaired with unapproved sealants and tape. To address these deficiencies, the FDA requires the company to engage an independent consultant to audit all manufacturing systems. The company must provide comprehensive remediation plans for its water systems, contamination control programs, and investigative procedures. Additionally, they are required to conduct a retrospective risk assessment for all drug products currently within their expiry period to ensure no safety risks remain for the public. Failure to address these violations promptly may lead to legal action, including product seizures or the withholding of new drug approvals.