Reply
Tue 19 Apr, 2011 10:23 pm
section 501(a)(2)(B) =
section 501
(Part a)
(the second in Part a)
(the B in the second) ?
Context:
During our October 25-29, 2010 inspection of your active pharmaceutical ingredient (API) manufacturing facility, Ningbo Smart Pharmaceutical Co. Ltd. located at #1 Yicheng Road, Xiaogang, Beilun District, Ningbo, China 315803, an investigator from the Food and Drug Administration (FDA) identified significant deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs. These deviations cause your APIs to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. ยง 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.
(a) is the first portion of section 501
(2) is the second point in part (a)
(B) is the second part in point (2)
It is entirely possible for there to be a second or third part of (B). It could be marked in a number of ways. (b1), (b2), (ii) are two examples.
Identifying a particular portion of a large document save a lot of time reading.
How to read section 501(a)(2)(B) ?
section five zero one...a...2...B?
@oristarA,
Quote:section five zero one...a...2...B?
Yes, that would do.
You could also say section five oh one aay, part two bee mate. (humour)
(You might sound like you have an Australian accent if you say it that way).
Stumble It!
Tweet This
Bookmark on Delicious
Share on Facebook
Share on MySpace