Insufficient quality, safety and processing capacity for cell processing
First written in FY2019. 3 of 5 entries say "Restated". Latest entry: FY2023.
0 other companies' latest entry also says "Mitigated".
- FY2023MitigatedAnnual report
「During the fiscal year, we expanded our manufacturing sites through rational investment.」
The expansion of manufacturing sites has helped address insufficient processing capacity. However, the risks associated with demand exceeding capacity, additional costs and securing personnel continue to be disclosed. - FY2022RestatedAnnual report
「We are also considering expanding or establishing processing facilities in anticipation of an acceleration in the pace of growth in the number of contracted projects. However, if demand from medical institutions grows faster than the expansion of this processing capacity and we are unable to accept all contracts because of capacity constraints」
Although we are working to ensure quality under the SOP and increase capacity through facilities, personnel and subcontracting, the risk remains that demand will exceed capacity. - FY2021RestatedAnnual report
「Since the sixth fiscal year, we have subcontracted part of the PFC-FD processing operations to external service providers, and are working to ensure the quality of the external providers' processing operations in the same manner described above.」
We are working to ensure quality under the SOP, expand facilities and processing operations, recruit and train personnel, and increase processing capacity through subcontracting, while the risks of quality deficiencies and insufficient capacity remain. - FY2020RestatedAnnual report
「We are also considering expanding or establishing processing facilities in anticipation of an acceleration in the pace of growth in the number of contracted projects. However, if demand from medical institutions grows faster than the expansion of this processing capacity and we are unable to accept all contracts because of capacity constraints」
Although we are working to ensure quality under the SOP and increase processing capacity through facilities, personnel and outsourcing, the risk remains that demand will exceed capacity. - FY2019First statedAnnual report
「If inadequate management results in processes being carried out in violation of the provisions of the Standard Operating Procedures (SOP), thereby adversely affecting the quality of the contract processing services, this could damage our reputation and hinder the advancement of our business」
Risks include SOP violations, demand exceeding the processing capacity of our facilities, equipment and technicians, and lost business opportunities resulting from staff shortages or attrition.