FDA 483 - Apotek Production & Laboratorier AB - January 29, 2026

From January 21 to January 29, 2026, the U.S. Food and Drug Administration (FDA) conducted an inspection of Apotek Production & Laboratorier AB, a sterile drug manufacturing facility located in Umea, Sweden. The inspection identified several critical deficiencies in the firm"s ability to ensure the sterility and quality of its drug products under the federal regulatory framework for safe manufacturing. Key violations included inadequate validation of sterile processes; specifically, airflow visualization studies were only performed while equipment was idle rather than during active production, failing to identify potential contamination risks. Investigators also observed staff exhibiting poor hygienic behaviors, such as touching sterile machine components with gloved hands and wearing improper eye protection that allowed particles to escape into the cleanroom. Additionally, the facility lacked a risk-based environmental monitoring program and failed to prove that its disinfectants were effective against local microbes. Data integrity concerns were also noted, as laboratory staff manually transcribed testing results without electronic backups or independent verification. Finally, the company’s testing for bacterial toxins was insufficient, relying on a single random sample to represent an entire production batch. While these findings do not represent a final agency determination, the company is required to submit a formal response to the FDA. This response must detail a comprehensive corrective action plan to address the highlighted safety and quality control gaps.