FDA 483 - Energetix Corporation - June 13, 2019

Energetix Corporation in Dahlonega, GA, was inspected from June 11-13, 2019. The inspection revealed significant deficiencies in the firm's quality control processes related to product complaint handling. Specifically, quality control personnel failed to adequately review and approve complaint investigations, including assessing the need for investigation, ensuring proper follow-up, and determining serious adverse event reporting requirements.