FDA 483 - Flamma USA LLC - June 20, 2025

An FDA inspection of Flamma USA LLC, an Active Pharmaceutical Ingredient (API) manufacturer in Malvern, PA, was conducted from June 16 to June 20, 2025. The inspection resulted in a Form FDA 483, identifying several significant observations related to manufacturing and quality control practices. Firstly, the company lacked established and followed written procedures for ensuring production equipment cleanliness immediately before use, with inspectors observing residue on equipment marked as 'clean' and ready for operations. Secondly, the firm's laboratory testing facilities were found to be inadequate, as Flamma USA LLC did not possess all necessary analytical equipment to perform comprehensive testing for identification, assay, optical rotation, and impurities of the drug substance for both release and stability samples. Finally, a critical deficiency was noted regarding change control; a modification to the drug substance dispensing process was implemented without formal change control documentation or a risk assessment. These observations indicate areas where Flamma USA LLC must implement corrective actions to ensure compliance with good manufacturing practices and maintain product quality and safety.