Inadequate Equipment Controls设备控制不足You failed to provide adequate data to demonstrate manufacturing systems were adequately maintained. Your firm did not monitor and acknowledge equipment alarms according to your established procedures. For example, our investigators observed (b)(4) alarms silenced without documented action. Likewise, temperature and humidity alarms for your stability chambers were disabled and were observed to be out of range when enabled.你未能提供足够的数据来证明制造系统得到了充分的维护。贵公司未按照既定程序监测和处理设备警报。例如，我们的调查人员发现，(b)(4)警报被静音，但没有记录相关处理措施。同样，稳定性试验箱的温度和湿度警报被禁用，在启用时发现其超出了规定范围。 In your response, you state your engineers acknowledged but did not document their evaluation and the corrective actions taken for the (b)(4) system alarms. Your response is inadequate because you did not provide sufficient detail of corrective actions or changes such as maintenance records or purchasing receipts for new filters. You commit to improving instructions for monitoring the stability chambers but did not consider a risk assessment or retrospective evaluation of stability chamber excursions not captured by your facility.在你的回复中，你称工程师已知悉(b)(4)系统警报，但未记录他们的评估情况以及所采取的纠正措施。你的回复并不充分，因为你没有详细说明纠正措施或变更情况，例如维护记录或购买收据。你承诺完善稳定性试验箱的监测指导说明，但未考虑对你公司未记录在案的稳定性试验箱偏差情况进行风险评估或回顾性评估。