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Thu 21 Apr, 2011 12:00 am
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.
@oristarA,
Yes wharehouse but not limited to just wharehousing.
Quote:the methods used in, or the facilities or controls used for ...holding...
this may also relate to The containers the product is stored, in the temparatures the product is stored at or any number of things that relate to Current Good Manufacturing Practice (CGMP).
http://www.tga.gov.au/docs/html/gmpcodau.htm
@dadpad,
Is a wharehouse like a kind of a warehouse where the wares are just piled in on top of each other, so you don't know where anything is?
@McTag,
McTag wrote:Is a wharehouse like a kind of a warehouse where the wares are just piled in on top of each other, so you don't know where anything is?
Its an area where prostitutes are kept prior to use McT, kinda like a nunnery.
Oristar my apologies for poor spelling of warehouse.... and stop laughing.
@oristarA,
manufacture, processing, packing, or
holding do not conform to
storing
The goods are being retained or held prior to being moved elsewhere.
Joe(
)Nation
@dadpad,
dadpad wrote:
McTag wrote:Is a wharehouse like a kind of a warehouse where the wares are just piled in on top of each other, so you don't know where anything is?
Its an area where prostitutes are kept prior to use McT, kinda like a nunnery.
Oristar my apologies for poor spelling of warehouse.... and stop laughing.
No need to apologize, sir.
But we all like to seize any opportunity to have fun.
So seriously,the FDA always fails to perform their duty to check out the wharehouse? I will report this to Mr. President Barack Obama. Thanks.
Wouldn't a place that contained things one couldn't find, be called a wherehouse?
Joe(just like my garage)Nation
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