# FDA 483 - Wasatch Product Development, LLC - March 04, 2016

Source: https://www.keypedia.com/records/483/wasatch-product-development-llc/882479a8-5347-415f-96cd-8b48a929a67a

> FDA 483 for Wasatch Product Development, LLC on March 04, 2016. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Wasatch Product Development, LLC
- Inspection Date: 2016-03-04
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Wasatch Product Development, LLC, an OTC drug contract manufacturer in Draper, UT, was cited for significant deficiencies in its quality control unit, including inadequate annual product reviews, change control, and out-of-specification investigations. The firm also failed to follow validation protocols and maintain specific cleaning validation documentation. Additionally, the firm did not calculate actual and theoretical yields during the packaging phase of drug products, indicating a lack of adherence to good manufacturing practices.

## Related Documents

- [483 - 2004-10-29](https://www.keypedia.com/records/483/wasatch-product-development-llc/7f74b38a-dfd7-4f55-8857-9f0ff2911010)
- [483 - 2011-03-11](https://www.keypedia.com/records/483/wasatch-product-development-llc/de50e2d4-9b8a-473c-ab97-62e8533a5af6)
- [483 - 2019-04-09](https://www.keypedia.com/records/483/wasatch-product-development-llc/495e2ef9-4878-430e-8488-275ebbe6692f)

## Related Officers

- [Jamie L. C. Dion](https://www.keypedia.com/people/jamie-l-c-dion/bea1370f-d56e-4eb1-8026-fcdec73d6eae)

Company: https://www.keypedia.com/companies/wasatch-product-development-llc/3545661f-a68f-404a-895d-c00555648648

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