FDA 483 - Excelvision - November 19, 2024

From November 12 to November 19, 2024, the FDA conducted an inspection of the Excelvision manufacturing facility located in Annonay, France. The resulting Form 483 report details several significant concerns regarding the firm’s ability to ensure the sterility and quality of drug products intended for the U.S. market. A major issue identified was the company’s inadequate investigation into over 120 consumer complaints reporting mold, black particles, and discoloration. Excelvision frequently attributed these issues to consumer misuse without supporting evidence or performing microbiological testing on returned samples. Additionally, staff members were found to be insufficiently trained to detect microbial growth during visual inspections. The inspection also highlighted failures in sterile processing controls. Airflow studies meant to demonstrate a protective environment were deficient, showing that improper operator movements and equipment setups disrupted the clean air supply. Furthermore, the company’s simulation tests failed to reflect real-world manufacturing challenges, such as long production pauses. Other violations included the use of cleaning agents that were not proven to be effective against mold, the use of filling equipment with physical cracks that hinder proper sanitization, and a lack of independent review for laboratory records, which led to inaccurate data reporting. To comply with federal regulations, Excelvision is required to respond to these observations with a detailed corrective action plan to address these safety and quality control lapses.