FDA 483 - Octapharma AB - September 19, 2023

An FDA inspection of Octapharma AB, a plasma derivatives manufacturer in Stockholm, Sweden, was conducted from September 11-19, 2023. The inspection resulted in an FDA 483 report detailing three primary observations. Firstly, the company did not consistently record and justify deviations from written production and process control procedures. Examples included a lack of documented operator training following updates to cleaning instructions, addressing human errors in temperature alarm monitoring, and ensuring correct material identification. A recent instance of an undocumented deviation during batch manufacturing was also noted. Secondly, critical manufacturing equipment, such as tanks and other apparatus used in plasma fractionation, exhibited visible corrosion, indicating inadequate maintenance that could compromise drug product quality. Lastly, Octapharma AB lacked established written procedures for in-process controls, specifically regarding the handling and disposition of recovered materials that failed quality testing, with multiple past instances of failed batches without a documented management process. These observations highlight the need for Octapharma AB to implement corrective actions to ensure compliance with good manufacturing practices under the Federal Food, Drug, and Cosmetic Act.