FDA 483 - HOYA LAMPHUN LTD - April 06, 2023

HOYA LAMPHUN LTD, a medical device manufacturer in Lamphun, Thailand, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate establishment and implementation of corrective and preventive action procedures and data analysis procedures. Additionally, the firm failed to adequately validate processes for its iSert brand IOL devices.