1Aseptic processing and sterility assurance
Procedmes designed to prevent microbiological contamination of dru g products pmporting to be sterile are not established, written and followed.
Inspection Record
Takeda Pharmaceutical Company Limited — FDA 483 Findings
Inspectors Steven M WeinmanThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Written procedures for cleaning and maintenance fail to include maintenance and cleaning schedules, description in sufficient detail ofmethods, equipment and m aterials used, description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance and instm ctions for protection of clean equipment from contamination prior to use.
3Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
4Equipment and facility
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drng product.
5Material and supplier control
fuvestigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same dm g product.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be sterile did not include adequate validation ofthe aseptic and sterilization process.
7Other quality system
Dmg products failing to meet established specifications are not rejected.
About this record
Extracted automatically from the document US FDA published on 2024-09-24. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
