# FDA WARNING_LETTER - Jessie Commodity Co., Ltd. - April 30, 2019

Source: https://www.globalkeysolutions.net/records/warning_letter/jessie-commodity-co-ltd/373a085d-0838-435b-8217-4531c845ca8e

> FDA WARNING_LETTER for Jessie Commodity Co., Ltd. on April 30, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Jessie Commodity Co., Ltd.
- Inspection Date: 2019-04-30
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued Warning Letter NO. 469-3 to Yuyao Jessie Commodity Co., Ltd. on April 18, 2019, regarding inaccurate listing information for their product "Mouth Fresh," NDC 51414-501. The FDA had previously notified the company of this deficiency on January 18, 2018, and subsequently removed the listing data from the online NDC Directory on March 5, 2018.

The core violation is the failure to provide accurate product listing information as required by Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the uploaded carton label image for "Mouth Fresh, NDC 51414-501" incorrectly depicts "Antibacterial Wet Wipes" with benzalkonium chloride 0.13% as the active ingredient, while the electronic listing identifies the product as "Mouth Fresh Spray" with cetylpyridinium chloride 0.05%.

This inaccuracy constitutes a prohibited act under Section 301(p) of the FD&C Act and misbrands the product under Section 502(o), making its introduction into interstate commerce a prohibited act under Section 301(a). The product's listing has been removed from the FDA's Online NDC Directory until corrections are made.

Yuyao Jessie Commodity Co.,

## 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/jessie-commodity-co-ltd/0cdaa5ca-4b35-4bd6-8ccc-dcfaef99f256

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