# FDA 483 - Rohto-Mentholatum (Vietnam) Co., Ltd. - March 16, 2018

Source: https://www.globalkeysolutions.net/records/483/rohto-mentholatum-vietnam-co-ltd/97566899-df8c-4661-a8c8-8e9a35a50d10

> FDA 483 for Rohto-Mentholatum (Vietnam) Co., Ltd. on March 16, 2018. 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: 2018-03-16
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Rohto Mentholatum (Vietnam) Co., Ltd. in Binh Duong Province, Vietnam, revealed significant deficiencies in the manufacturing of OTC sterile drug products. The firm's environmental monitoring, aseptic processing controls, media fill simulations, and microbiological testing procedures were found to be inadequate. These issues collectively indicate a lack of robust controls necessary to ensure the sterility and quality of their sterile drug products.

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- [483 - 2015-04-06](https://www.globalkeysolutions.net/records/483/rohto-mentholatum-vietnam-co-ltd/3ecd5cd2-c970-469b-8359-8972fb066fdc)
- [483 - 2019-11-01](https://www.globalkeysolutions.net/records/483/rohto-mentholatum-vietnam-co-ltd/f877cbde-1e3a-4e3c-a9d3-cd44825d4eab)

## Related Officers

- [Jose A. Cruz Gonzalez](https://www.globalkeysolutions.net/people/jose-a-cruz-gonzalez/a005cff1-0a90-4396-82c4-de4b0a579374)

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

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321