# FDA 483 - Premium Production LLC - April 02, 2021

Source: https://www.keypedia.com/records/483/premium-production-llc/e2f75f52-6f3f-4ab9-9afc-e2bad63500e5

> FDA 483 for Premium Production LLC on April 02, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Premium Production LLC
- Inspection Date: 2021-04-02
- Product Type: other
- Office Name: Denver District Office
- Summary: Premium Production LLC, a dietary supplement manufacturer in Saint George, UT, was inspected by the FDA from March 29 to April 2, 2021. The inspection revealed nine significant violations, many of which were repeat observations from a previous 2019 inspection, primarily concerning the lack of established and followed written procedures for various quality control, manufacturing, and record-keeping operations. The firm failed to ensure product quality, proper documentation, and supplier qualification, indicating systemic issues in their quality management system.

## Related Documents

- [WARNING_LETTER - 2019-02-08](https://www.keypedia.com/records/warning_letter/premium-production-llc/7d62a62a-3619-45de-b197-67764344050b)

## Related Officers

- [Jennifer A. Robinson](https://www.keypedia.com/people/jennifer-a-robinson/a34d6842-7cc1-4976-8ca7-2b57f1cff756)
- [Matthew A. Johnson](https://www.keypedia.com/people/matthew-a-johnson/e94e2d6a-1705-4ba4-b777-d514970e5371)

Company: https://www.keypedia.com/companies/premium-production-llc/72b2bb76-3881-4313-8d93-fa4776d8696b

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