FDA 483 - Infupharm, LLC - September 27, 2011

An FDA inspection of Infupharma, LLC, a compounding pharmacy in Hollywood, FL, was conducted across several dates: July 18-22, September 19-23, and September 27, 2011. The inspection revealed a significant observation regarding the firm's procedures for preventing microbiological contamination of sterile drug products. Specifically, Infupharma was found to have inadequate established, written, or followed procedures for handling and storing components and drug products to prevent contamination. A primary example of this deficiency involved the firm's repackaging operations for Avastin (bevacizumab). Infupharma frequently used single-use vials of Avastin, an intravenous infusion solution, as multiple-use vials when repackaging the drug into individual syringes for intraocular injection. This practice contradicted the manufacturer's recommendations, which state that unused portions of Avastin vials should be discarded after opening due to the absence of preservatives. The firm failed to consider the microbiological, physical, and chemical stability implications of using these open vials multiple times. These inspectional observations, documented under an FDA Form 483, indicate potential non-compliance with fundamental quality control principles for sterile compounding. Infupharma is expected to review these findings and implement appropriate corrective actions to ensure the safety and quality of its compounded sterile drug products.