FDA 483 - Tiller MIND BODY, Inc. - July 13, 2023

An FDA inspection of TILLER MIND BODY, Inc. in San Antonio, TX, a manufacturer of the Class 2 LIBBE Colon Hydrotherapy System, revealed significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for complaint handling, including Medical Device Report (MDR) determination, finished device acceptance criteria, and maintaining complete device history records. These issues indicate a lack of control over critical manufacturing and post-market surveillance processes.