Energetix CorporationJune 13, 2019

FDA 483 - Energetix Corporation - June 13, 2019

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Record Details

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.

Company: Energetix Corporation
Inspection Date: June 13, 2019
Product Type: Drugs
Office: Atlanta District Office
Person: Joseph F. Owens (Consumer Safety)

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ID · 2ada1f1f-9e95-4cdd-86df-24d2dc74f176