FDA 483 - ID Biomedical Corporation of Quebec - May 20, 2022

From May 12 to May 20, 2022, the U.S. Food and Drug Administration (FDA) conducted an inspection of ID Biomedical Corporation of Quebec, a licensed manufacturer of biological products. The inspection revealed several significant failures in quality assurance and manufacturing protocols. Major concerns included an inadequate investigation into missing endotoxin test data and deficient complaint management. Specifically, the firm failed to notify the FDA of defective syringes for the FluLaval product, which exhibited leaks and cracks, and did not consistently respond to customer complaints. Additionally, the facility's sterile processing procedures were found to be lacking, involving the use of non-sterile materials in cleanrooms, poor maintenance of protective gear, and insufficient environmental monitoring. The FDA also noted that preventative maintenance for critical equipment was incomplete and that water sampling for manufacturing was not representative of actual use. These findings fall under the regulatory framework for biological drug manufacturing. Although these observations are not a final determination of non-compliance, the company is expected to provide a written response to the FDA detailing its corrective actions and plans to resolve the identified issues to ensure future product safety.