The respective audit report was not available. 无审计报告
There was no evidence upon which to base the approved manufacturer decision 无数据支持审批决定
The address of a supplier site differed from the address on the audit report 供应商实际位置同报告位置不同
In the audit reports it was not apparent what had actually been audited 具体审计内容不清
The maintenance and control of the approved supplier list was not robust 合格供应商清单不确定
API was received although an audit specified that the supplier was no longer approved 仍从未批准供应商处购买API
Risk based audit planning defines no maximum time frequency 以风险管理为基础的审计未定义审计周期
Quality Assurance Agreement was not kept up to date. QAA未及时更新
Quality Assurance Agreement failed to adequately describe transportation conditions. QAA未描述运输要求
Approved supplier list was inadequate, e.g. not all suppliers were listed and some suppliers were listed that should not have been. 供应商清单不充分，有些未列，有些多列
Supplier audit SOP did not cover API suppliers and other services. 审计SOP未包括API及服务供应商
After concluding that an API supplier was not suitable for the supply, the API already received and held on stock was not quarantined and rejected. 审计不合格的供应商，其API产品未受控制