483
Daiichi Sankyo Co., Ltd. Odawara PlantDaiichi Sankyo Co., Ltd. Odawara Plant – FDA 483, Jan 25, 2019
Record Details
An FDA Form 483 was issued to Daiichi Sankyo Chemical Pharma Co., Ltd. in Odawara, Japan, an API manufacturer. The inspection revealed deficiencies related to the retention of documentation for primary reference standards, the suitability determination of secondary reference standards, stability testing practices for drug substance intermediates, and the thoroughness of investigations into unexplained discrepancies.
View Company Profile
ID · aeedd5d2-72f2-4896-a258-2bbd6991fadf
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.