483
Nippon Kayaku Pharmatech Co., Ltd.Nippon Kayaku Pharmatech Co., Ltd. – FDA 483, Nov 26, 2019
Record Details
An FDA inspection of Fuji Yakuhin Co., Ltd. in Toyama-shi, Japan, a manufacturer of sterile drug products, revealed significant deficiencies. Observations included inadequate aseptic process validation, insufficient disinfectant efficacy studies, and critical issues with electronic record integrity and retention. Additionally, the firm failed to adequately qualify suppliers for container and closure components.
View Company Profile
ID · 15f40bdb-099d-4908-9b4f-1e6bfc4e13f9
Other documents for Nippon Kayaku Pharmatech Co., Ltd.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.