Warning Letters
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
缩写解释：
CGMP:current good manufacturing practice
QSR:Quality SystemRegulation
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medline-industries-lp-723866-03252026
the FDA issued afinal rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. The revised part 820, referred to as the Quality Management System Regulation (QMSR), became effective on February 2, 2026. Your most recent inspection on December 1, 2025 to December 12, 2025 was conducted pursuant to the QS Regulation, which was in effect at the time of the inspection.
可学习内容：
1.FDA审核老师的审核逻辑、关注维度、审查重点！
2.违规条款与企业具体行为之间的对应关系，深化对法规条款的理解
3.不同违规行为的严重程度及FDA的执法措施
Inspectional Observation
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations可学习内容：
1.FDA审核老师的审核角度、关注维度、审查重点！
2.违规条款与企业具体行为之间的对应关系，深化对法规条款的理解
学习这些实际案例，不是“看别人笑话”，而是“照镜子”，用别人的“踩坑成本”，换自己的“避坑能力”。——研究审核老师的审查重点，剖析条款与行为的对应关系，跟踪监管形势演变，让自己提前挡住那些“迟早会来”的问题，将案例教训转化为体系改进措施，避免同样问题在自己企业发生！
10个月宝宝每天需要喝多少奶粉？
