FDA 483 - Holistic Technologies, LLC - August 23, 2019

Holistic Technologies, LLC in Milton, MA, was inspected and received a Form FDA-483 with five observations. The inspection revealed significant deficiencies in the firm's quality system, primarily concerning the lack of established procedures for critical manufacturing processes. These issues include missing procedures for finished device acceptance, supplier control, quality audits, design control, and device history records, indicating a fundamental breakdown in quality management.