# FDA 483 - Otsuka Pharmaceutical Development & Commercialization, Inc - May 19, 2017

Source: https://www.keypedia.com/records/483/otsuka-pharmaceutical-development-commercialization-inc/39edbca6-da40-46e2-9927-8ecfdc44b721

> FDA 483 for Otsuka Pharmaceutical Development & Commercialization, Inc on May 19, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Otsuka Pharmaceutical Development & Commercialization, Inc
- Inspection Date: 2017-05-19
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Otsuka America Pharmaceutical, Inc. in Rockville, MD, a specification developer, revealed significant deficiencies in their quality system. Observations included inadequate design verification for products like BreathTek UPT collection bags and Pranactin-Citric, insufficient validation of device software, and failures in establishing and implementing corrective and preventive actions. Additionally, the firm did not perform quality audits at defined intervals or with sufficient frequency.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-m-simpson/3c0113ae-d846-4e37-aafa-13d58c465fa3)

Company: https://www.keypedia.com/companies/otsuka-pharmaceutical-development-commercialization-inc/03896536-2cca-444e-b073-5c54859f3e6f

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e