# FDA 483 - Energetix Corporation - June 13, 2019

Source: https://www.keypedia.com/records/483/energetix-corporation/2ada1f1f-9e95-4cdd-86df-24d2dc74f176

> FDA 483 for Energetix Corporation on June 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Energetix Corporation
- Inspection Date: 2019-06-13
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: 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.

## Related Officers

- [Consumer Safety](https://www.keypedia.com/people/joseph-f-owens/68cda862-335d-4de4-8abd-bf83a96a76bb)

Company: https://www.keypedia.com/companies/energetix-corporation/30efec5c-708e-438c-9e1e-682414219150

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7