FDA 483 - Octapharma S.A.S. - December 06, 2022

An FDA inspection conducted from November 28 to December 6, 2022, at Octapharma S.A.S., a biologics blood product manufacturer in Lingolsheim, France, revealed multiple significant deficiencies. The observations, documented on an FDA Form 483, indicate potential non-compliance with current Good Manufacturing Practices (cGMP) regulations. Key issues included a failure to thoroughly assess discrepancies for product impact, such as pH deviations and pest intrusions, and to adequately investigate root causes. Inspectors noted that written production and process control procedures were not consistently followed, leading to bioburden excursions and improper operator practices during manufacturing. Contamination risks were further highlighted by foreign materials, like silicone pieces, found in drug product lines, indicating inadequate component handling. The inspection also identified insufficient employee training, contributing to errors in equipment operation and aseptic techniques, and ineffective bio-cleaning. Equipment and utensils were not always properly cleaned, maintained, or sanitized, with an inadequate preventive maintenance program cited. Furthermore, the facility's buildings exhibited structural deficiencies, including rust, holes, and water leaks, compromising environmental controls. An inadequate pest control system resulted in numerous reports of spiders, rodents, and insects in various production and classified areas. Regarding specific product controls, there was a lack of assurance that Immune Globulin Intravenous, Human lots met donor pooling criteria. Quality control test methods lacked validated storage conditions, and data integrity was compromised by the absence of routine data audit checks for batch records. Octapharma S.A.S. is required to respond to these observations with corrective actions to ensure compliance and product quality.