Taylor Healthcare Products, Inc. – FDA 483, Jul 8, 2026

An FDA inspection of Taylor Healthcare Products, Inc. in Spring, TX, revealed significant deficiencies in their quality management system related to their Class 2 sharps containers. Observations included a lack of procedures for monitoring and controlling outsourced processes, inadequate complaint handling, and a failure to establish essential quality system documentation. These issues indicate a fundamental lack of control over critical aspects of device manufacturing and distribution.