# FDA 483 - Aspen Co-Pak, LLC - April 14, 2016

Source: https://www.globalkeysolutions.net/records/483/aspen-co-pak-llc/937e6c6f-9ffc-48f5-b97e-27bcd6812eb3

> FDA 483 for Aspen Co-Pak, LLC on April 14, 2016. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aspen Co-Pak, LLC
- Inspection Date: 2016-04-14
- Product Type: other
- Office Name: Denver District Office
- Summary: An FDA inspection of Aspen Co-Pak, LLC in Lindon, UT, a dietary supplement and food manufacturer, revealed ten significant observations, many of which were repeat findings from a previous inspection. The firm failed to establish critical specifications for components and finished products, did not perform identity testing, and lacked proper quality control procedures and batch record documentation. Additionally, the facility exhibited unsanitary conditions and lacked procedures for returned dietary supplements, indicating systemic deficiencies in their manufacturing practices.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/richard-t-jensen/5c57619e-09b2-4ba3-82ee-3402dc189031)
- [Larisa E Pavlick](https://www.globalkeysolutions.net/people/larisa-e-pavlick/b4667130-b100-4be8-b565-1c334b75c852)
- [Isabel Y. Espinosa](https://www.globalkeysolutions.net/people/isabel-y-espinosa/a7703143-0833-4537-b371-ce25668f4fee)

Company: https://www.globalkeysolutions.net/companies/aspen-co-pak-llc/96c05e75-7d9f-4c49-91f0-d9e4b3f81bec

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