# FDA 483 - Aphena Pharma Solutions - Tennessee LLC - October 15, 2021

Source: https://www.keypedia.com/records/483/aphena-pharma-solutions-tennessee-llc/12c2afbf-e8f0-441b-a63d-975d8eddc615

> FDA 483 for Aphena Pharma Solutions - Tennessee LLC on October 15, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aphena Pharma Solutions - Tennessee LLC
- Inspection Date: 2021-10-15
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Aphena Pharma Solutions - Tennessee LLC in Cookeville, TN, a drug packager, identified two significant observations. The firm failed to exercise strict control over drug product labeling, lacking a secured storage area and written procedures for labeling transfer and use. Additionally, packaging equipment was not appropriately qualified across the full range of container and closure sizes for specific drug products.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

Company: https://www.keypedia.com/companies/aphena-pharma-solutions-tennessee-llc/6ae4a9a0-c887-4612-9416-fda8a1f661c9

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea