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Fdanews. com/ext/files/Pfizer-483. pdf. Form 483 Notes Several Issues With Genzyme Kidney Drug disease drug have resulted in a multiitem Form 483 for Genzyme. Page 11 GAO says FDA oversight is at high risk for mismanagement. Page 12 Pfizer recalls pain drug prostate drug antidepressant. 27 2010 to Dec. 9 2010 inspection. McNeil also used bottles that may have been exposed to haloanisole to package Tylenol 8 Hour caplets. Ema.europa.eu/docs/enGB/document library/Other/2011/02/WC500102054. pdf....
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Sterility issues can lead to contamination and infection.
Manufacturers and distributors are required to file sterility issues.
Fill out the form with details of the sterility issues and any related information.
The purpose is to ensure public safety and prevent the spread of infections.
Details of the products affected, root cause of the sterility issues, and any corrective actions taken.
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