# FDA 483 - Rohto-Mentholatum (Vietnam) Co., Ltd. - November 01, 2019

Source: https://www.globalkeysolutions.net/records/483/rohto-mentholatum-vietnam-co-ltd/f877cbde-1e3a-4e3c-a9d3-cd44825d4eab

> FDA 483 for Rohto-Mentholatum (Vietnam) Co., Ltd. on November 01, 2019. 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: 2019-11-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Rohto-Mentholatum (Vietnam) Co., Ltd. revealed significant deficiencies across multiple areas of sterile drug product manufacturing. Key issues included inadequate environmental monitoring in aseptic processing, insufficient process validation, and a failure to thoroughly investigate out-of-specification results. Additionally, the firm demonstrated poor computer system controls, deficient laboratory testing procedures, and an incomplete disinfectant efficacy study, indicating a broad lack of adherence to good manufacturing practices.

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## Related Officers

- [Bijoy Panicker](https://www.globalkeysolutions.net/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1