FDA警告信的一句,(b)(4)forlenspowersbetween(b)(4).特别搞不懂啥意思,觉得语法也不对呀.Failuretoestablishandmaintainprocesscontrolproceduresthatdescribeanyprocesscontrolsnecessarytoensureconformancetospecificati

Question

FDA警告信的一句,(b)(4) for lens powers between (b)(4).特别搞不懂啥意思,觉得语法也不对呀.
Failure to establish and maintain processcontrol procedures that describe any process controls necessary to ensureconformance to specifications,as required by 21 CFR 820.70(a).For example,your firm’s procedure,F2-II-06,“Power Inspection,” states that the tolerancelimit of the back vertex power measurement shouldbe within (b)(4) for lens powers between (b)(4).However,review of your firm’s DeviceHistory Record,(b)(4),shows that the back vertex specification measurementsare not always met.

Answer 1

(b)(4)是指隐藏了需要保密的商业信息
其他情况有不同的编号对应 比如个人隐私信息 会替换成(b)(6)
就好比我们为了保密 就把一个人的真是名字换成“某某”或者“ABC”
这里这种 应该是比较规范的商业或者法律用法吧
具体每一个(b)(4)背后隐藏了什么信息 就不清楚了 但是你看不懂的话 跟语法没啥关系.