# FDA WARNING_LETTER - Lydia Co. Ltd. - July 04, 2023

Source: https://www.keypedia.com/records/warning_letter/lydia-co-ltd/f0290d5e-2540-4a67-adf8-0ae036ab8650

> FDA WARNING_LETTER for Lydia Co. Ltd. on July 04, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Lydia Co. Ltd.
- Inspection Date: 2023-07-04
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Ho Dong Yang on June 26, 2023, regarding discrepancies in drug listing information for eight products: Hot Pap Cataplasma, Amuldy Sports Gel, Zenol Cool, Antiphlamine, Mentholatum, New Hanbang Col Cap, Nocold-S, and Albothyl.

The FDA's review of the firm's electronic Drug Registration and Listing System (eDRLS) submissions revealed contradictory information between the product labeling and the electronic listing files. This follows a March 17, 2023, deficiency letter and a May 1, 2023, data removal notification, which resulted in the products' data being removed from FDA’s Online NDC Directory.

Violations include:
*   **Hot Pap Cataplasma (NDC 72988-0007):** Mismatched active ingredients (labeling includes methyl salicylate and vanillyl nonylamide; listing only methyl salicylate) and incomplete package quantity information (labeling indicates 5 sheets; listing only 1 sheet). This violates 21 CFR 207.49(a)(4) and 21 CFR 207.49(a)(2).
*   **Amuldy Sports Gel (NDC 72988-0023):** Mismatched active ingredients (labeling includes ment

## Related Officers

- [Director](https://www.keypedia.com/people/tina-smith/5d590654-a270-4f3f-833f-d6fe13ca8c05)

Company: https://www.keypedia.com/companies/lydia-co-ltd/4d16dcee-c124-4394-80d8-a89c34e9ad1d

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