FDA 483 - Alcon Research LLC - August 04, 2017

Alcon Research, Ltd. in Fort Worth, TX, a sterile drug/device manufacturer, was cited for two observations during an FDA inspection. The inspection revealed deficiencies in procedures designed to prevent microbiological contamination of sterile drug products, including inadequate SOPs for HEPA transfer carts and issues with personnel monitoring. Additionally, the firm failed to establish appropriate finished product release and shelf-life specifications for degradants/impurities for a drug product.