FDA 483 - Healthy Spirit, LLC - November 03, 2023

Healthy Spirit, LLC, a specification developer in Baltimore, MD, was cited for seven significant quality system deficiencies during an FDA inspection from October 31 to November 3, 2023. Many of these observations, including issues with design control, purchasing, non-conforming product, CAPA, installation, and servicing procedures for their Easy Rest Adjustable Sleep System, were repeat findings from a previous inspection in 2017. The firm also lacked adequate procedures for receiving and evaluating complaints.