# FDA 483 - Good Health Manufacturing - August 20, 2021

Source: https://www.keypedia.com/records/483/good-health-manufacturing/e2e782d4-7879-4449-b298-48ba030aee9d

> FDA 483 for Good Health Manufacturing on August 20, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Good Health Manufacturing
- Inspection Date: 2021-08-20
- Product Type: other
- Office Name: Denver District Office
- Summary: Good Health Manufacturing received a Form 483 detailing multiple significant violations related to the manufacturing and control of dietary supplements. Observations included inadequate cleaning and sanitization, poor contamination control during manufacturing, and a lack of established product and component specifications. The firm also failed to maintain proper documentation for supplier qualification, batch production records, and master manufacturing records, alongside issues with environmental controls, personnel gowning, and equipment suitability and calibration.

## Related Officers

- [Gary C. Pecic](https://www.keypedia.com/people/gary-c-pecic/37cf1f4d-6b1c-4be6-8adb-89cf685f5022)
- [Siobhan G. Taylor](https://www.keypedia.com/people/siobhan-g-taylor/91b1b7f3-29ca-4271-b12c-0ec5a01e47ac)

Company: https://www.keypedia.com/companies/good-health-manufacturing/8d87eb1d-8759-4503-8e21-5a5c672fe98f

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face