1Deviation, CAPA, and investigation
Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
Inspection Record
Toyobo Co. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
3Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
4Training and personnel
Production personnel were not practicing good sanitation and health habits.
5Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
6Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
7Laboratory and QC controls
The suitability of all testing methods is not verified under actual conditions of use.
8Training and personnel
Employees are not given training in the particular operations they perform as part of their function and current good manufacturing practices.
9Documentation and records
Batch production and control records do not include the weights and measures of components used in the course of processing each batch of drug product produced.
10Process validation
Written production and process control procedures are not followed in the execution of production and process control functions.
11Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
About this record
Extracted automatically from the document US FDA published on 2021-09-03. 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.
