# FDA WARNING_LETTER - Aphena Pharma Solutions-Tennessee, LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/warning_letter/aphena-pharma-solutions-tennessee-llc/e56fd462-387c-4096-af1e-f92d5771f1c8

> FDA WARNING_LETTER for Aphena Pharma Solutions-Tennessee, LLC on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Aphena Pharma Solutions-Tennessee, LLC
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Aphena Pharma Solutions-Tennessee, LLC on December 5, 2017, regarding inaccurate drug product listing information for Fenofibrate 48mg (NDC 43353-248) and Montelukast Sodium (NDC 43353-252). This follows previous FDA letters on August 24, 2017, and October 12, 2017, which were not addressed.

The violations stem from the firm's failure to include correct copies of carton labels in their product listings, as required by Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the Fenofibrate 48mg listing included a carton label for Fenofibrate 145mg, and the Montelukast Sodium 5mg listing included a carton label for Montelukast Sodium 10mg.

These inaccuracies constitute a failure to fulfill listing obligations under Section 510(j), which is prohibited under Section 301(p) of the FD&C Act. Furthermore, this misbrands the products under Section 502(o), making their introduction into interstate commerce prohibited under Section 301(a).

As a result, the listing data for both products have been removed from the FDA's online NDC Directory. The firm must

## Related Officers

- [Maria Rossana R. Cook](https://www.globalkeysolutions.net/people/maria-rossana-r-cook/99e48d03-a1a5-47b7-a1ec-7dec8988dd44)

Company: https://www.globalkeysolutions.net/companies/aphena-pharma-solutions-tennessee-llc/aaeefdfe-49eb-43f5-9a87-e8e66e3d5481

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c