FDA 483 - Optical Connection LLC - January 16, 2020

This FDA Form 483 was issued to Optical Connection LLC, an initial importer/distributor of class II contact lenses in San Diego, CA, following an inspection from January 8-16, 2020. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for complaint handling, CAPA, acceptance activities, nonconforming product control, document control, and a complete lack of documented personnel training. The firm's President acknowledged that several procedures were either not established or not followed.