FDA 483 - Pharmaloop, S.L. - April 16, 2024

An FDA inspection conducted at Pharmaloop, S.L. in Alcala de Henares, Madrid, Spain, from April 8 to April 16, 2024, resulted in the issuance of a Form FDA 483. The inspection identified several deficiencies in the company's drug manufacturing processes. Among the significant observations, the facility was cited for failing to adequately identify organisms involved in environmental monitoring incidents, even when colony counts did not exceed action limits. This suggests a gap in their microbial control and investigation procedures. Furthermore, issues were noted with the aseptic filling process validation. Specifically, the media fill protocol and report for March 2024 did not clearly document the dosing of water, indicating potential shortcomings in simulating actual production conditions or in documentation practices. A critical observation highlighted the company's failure to appropriately sample, test, or examine raw materials, components, and closures used in drug product manufacturing. The report specifically noted a lack of testing for a particular limit in a raw material, which is essential for ensuring product quality and patient safety. These observations collectively indicate a need for enhanced quality control, improved validation protocols, and more rigorous raw material testing to ensure compliance with good manufacturing practices for drug products. Pharmaloop, S.L. is expected to address these findings with comprehensive corrective and preventive actions.