FDA Issues Warning Letter to Rechon Life Sciences for Major CGMP Violations

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Rechon Life Sciences in Sweden following a CGMP inspection that uncovered serious compliance failures. The agency determined that sterile drug products manufactured at the site are “adulterated” under the Federal Food, Drug, and Cosmetic Act.

The FDA identified four critical deficiencies: (1) inadequate control of microbiological contamination, including direct contact of critical surfaces with gloved hands and insufficient environmental monitoring; (2) poor investigations of deviations and out-of-specification (OOS) results, with weak root cause analyses and unsupported invalidations of data; (3) deficiencies in cleaning and disinfection, such as unvalidated decontamination processes and recurring contamination with spore-forming organisms; and (4) facility maintenance problems, including peeling paint, rust, and structural defects in controlled areas.

The agency requires a comprehensive corrective and preventive action (CAPA) plan, including system upgrades, validated cleaning procedures, and strengthened quality oversight.

03-09-2025