# FDA 483 - Bodyhealth.com, LLC - August 20, 2021

Source: https://www.keypedia.com/records/483/bodyhealthcom-llc/2ec1fba7-139c-4fa3-bfe0-634db9f841cb

> FDA 483 for Bodyhealth.com, LLC on August 20, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bodyhealth.com, LLC
- Inspection Date: 2021-08-20
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Bodyhealth.com, LLC, a dietary supplement manufacturer in Dunedin, FL, revealed significant deficiencies in their quality control systems. The firm failed to establish critical specifications for components and finished products, qualify suppliers, or maintain proper batch production and calibration records. These issues indicate a severe lack of adherence to good manufacturing practices for dietary supplements.

## Related Documents

- [WARNING_LETTER - 2021-01-19](https://www.keypedia.com/records/warning_letter/bodyhealthcom-llc/2aa77027-7c5b-4262-baaa-e670b0d698b1)
- [WARNING_LETTER - 2014-10-31](https://www.keypedia.com/records/warning_letter/bodyhealthcom-llc/9821a7c3-8907-4267-a26a-be7953acf208)

## Related Officers

- [Aaron J. Fox](https://www.keypedia.com/people/aaron-j-fox/0a230544-8f5a-4979-afc0-736bc68f3e03)

Company: https://www.keypedia.com/companies/bodyhealthcom-llc/600ec258-0d55-4445-93ff-c7133730c18d

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