# FDA 483 - Rohto Pharmaceutical Co., Ltd. (Ueno Plant) - March 08, 2023

Source: https://www.globalkeysolutions.net/records/483/rohto-pharmaceutical-co-ltd-ueno-plant/d8ada17f-9065-4c87-836c-6d4b478a7741

> FDA 483 for Rohto Pharmaceutical Co., Ltd. (Ueno Plant) on March 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rohto Pharmaceutical Co., Ltd. (Ueno Plant)
- Inspection Date: 2023-03-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Rohto Pharmaceutical Co., Ltd (Ueno Plant) received a Form 483 following an inspection of its sterile drug manufacturing facility in Iga Mie, Japan. The observations primarily highlight significant deficiencies in aseptic processing controls, including inadequate procedures for preventing microbiological contamination, insufficient production and process controls, and failures in complaint handling and laboratory testing. These issues indicate a lack of robust quality systems necessary to ensure the sterility and quality of drug products distributed to the U.S. market.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/michael-e-maselli/84b393a9-864c-4150-a636-d4ee4a60c8af)
- [Investigator](https://www.globalkeysolutions.net/people/michele-perry-williams/80741e95-8df3-41c9-b9b8-499fcb97921d)

Company: https://www.globalkeysolutions.net/companies/rohto-pharmaceutical-co-ltd-ueno-plant/43466404-a070-48c2-b431-c1009113e523

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