# FDA 483 - Health Genesis Corporation - February 18, 2020

Source: https://www.keypedia.com/records/483/health-genesis-corporation/2da452dd-de1a-489a-ad9d-067c3a54d264

> FDA 483 for Health Genesis Corporation on February 18, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Health Genesis Corporation
- Inspection Date: 2020-02-18
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Health Genesis Corporation, a dietary supplement manufacturer in Davie, FL, was cited with nine observations during an FDA inspection from January to February 2020. The inspection revealed significant deficiencies in quality control, material handling, equipment calibration, and record-keeping, many of which were recurring issues from previous inspections. These findings indicate a systemic lack of adherence to good manufacturing practices for dietary supplements.

## Related Officers

- [Karl Hezel](https://www.keypedia.com/people/karl-hezel/4f660e27-c16c-4d62-9161-273bd55852d8)

Company: https://www.keypedia.com/companies/health-genesis-corporation/10143f4e-ae99-460b-a369-bab3e4abbc08

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6