FDA 483 - Cyalume Technologies, Inc. - October 19, 2022

Cyalume Technologies, Inc. in W Springfield, MA, received a Form FDA 483 following an inspection related to their medical device manufacturing. The inspection revealed significant deficiencies in the firm's design control procedures, specifically concerning design changes and design output for their Single-Use Vaginal Speculum with Illumination Insert. These issues indicate a lack of proper documentation, review, and validation for critical aspects of device design and manufacturing changes.