FDA 483 - Halo Dream, Inc ( formerly Halo Innovations, Inc.) - November 19, 2021

An FDA inspection of Halo Innovations, Inc. in New York, NY, revealed two significant issues. The firm failed to establish written procedures for electronic Medical Device Reporting (eMDR) and did not adequately document design validation results in their design history file. These observations indicate deficiencies in quality system procedures and documentation practices.