FDA 483 - Alcon Research LLC - July 24, 2014

Alcon Research, Ltd. in Fort Worth, TX, a non-clinical laboratory, was inspected by the FDA. The inspection revealed significant deficiencies related to standard operating procedures for animal care, including inadequate monitoring for yeast/mold and unperformed quality control. Additionally, issues were noted with data integrity concerning lot number discrepancies and a lack of established procedures for documenting the receipt and final disposition of test and control articles.