Magazine article from our research archive:
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The Use of Complaining
- Article from:
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Pharmaceutical Technology
- Article date:
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June 1, 2008
- Author:
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Copyright informationCopyright Advanstar Communications, Inc. Jun 2008. Provided by ProQuest LLC. (Hide copyright information)
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Control
Customers complaining lead to some serious explaining.
A precipitated inspection
"Back in the days when FDA sometimes followed up on complaints by sending out the local inspector, we received an inspection following a complaint about a suspension product we manufactured," says our GMP Agentin-Place. "First, you must understand that the FDA was usually hosted by two persons at our site, my boss who was a manager in quality, and an assistant director from production. Both of them were gone, so both of us substitutes got to host our first inspection!
"The inspector looked at the retain samples, then the release-testing record for the complaint batch. It looked good until he noticed ...
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