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

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.