# FDA 483 - Rohto-Mentholatum (Vietnam) Co., Ltd. - April 14, 2026

Source: https://www.keypedia.com/records/483/rohto-mentholatum-vietnam-co-ltd/33576476-df9f-4c85-b993-fcfe12e722b3

> FDA 483 for Rohto-Mentholatum (Vietnam) Co., Ltd. on April 14, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rohto-Mentholatum (Vietnam) Co., Ltd.
- Inspection Date: 2026-04-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Rohto-Mentholatum (Vietnam) Co., Ltd., an OTC drug manufacturer, was inspected and found to have significant deficiencies across its aseptic processing operations. Observations included widespread failures in following procedures to prevent microbial contamination, unreliable laboratory and cleaning records, inadequate validation of aseptic processes, and insufficient investigation into product discrepancies. These issues indicate a severe lack of control over sterile manufacturing and quality assurance.

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## Related Officers

- [Hung H. Do](https://www.keypedia.com/people/hung-h-do/580f78ba-ed7a-4c10-8f4c-a99d0af7206e)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.keypedia.com/companies/rohto-mentholatum-vietnam-co-ltd/eac5ed6a-913a-43e0-b3cc-63a33485acd7

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8