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jcc911 jcc911 is offline
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Join Date: Jan 2004
Location: Milwaukee, WI
Posts: 3,360
Some do and others just contract the work. Generics can be manufactured by anyone as long as they adhere to an OTC or other compendial monograph.
The problem with the audit reports is that it is only one side of the story or just the auditors perspective. If the auditor is trying to build a case, the they portray findings worse than actual. The biggest problem is that the new compliance officers do not consider logic and science when performing their audits and have the mentality that the manufacturer is guilty. So in that aspect, yes the reports can be exaggerated.
Beyond that what makes things worse is when the media tries to interpret these reports as they really do not understand them and their presention of the data to the public is grossly incorrect.
Old 01-15-2013, 11:30 AM
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