FDA 483 - Little Sparrows Technologies, Inc. - October 20, 2021

An FDA inspection of Little Sparrows Technologies, Inc. in Newtonville, MA, a manufacturer of the Bili-Hut Neonatal Phototherapy device, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for design control, maintain a complete design history file, and ensure proper quality audits. Additionally, issues were noted with device history records and personnel training documentation.