# FDA 483 - Energium Health - November 30, 2021

Source: https://www.globalkeysolutions.net/records/483/energium-health/c89710a3-bab0-43d6-8086-478932763eab

> FDA 483 for Energium Health on November 30, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Energium Health
- Inspection Date: 2021-11-30
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Energium Health in Sterling Heights, MI, a medical device establishment, revealed two significant observations. The firm was cited for failing to establish adequate quality system procedures and for lacking procedures to control labeling activities, specifically re-labeling. These issues indicate a fundamental lack of documented controls within their operations.

## Related Officers

- [David J. Gasparovich](https://www.globalkeysolutions.net/people/david-j-gasparovich/478888db-d4b3-481a-89f5-ee234a160f07)

Company: https://www.globalkeysolutions.net/companies/energium-health/5be0da8c-bc6a-4260-95dc-8af52db86f5a

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0