Simplifying Global Compliance
The QMN Weekly Bulletin
Warning Letter Dings Pfizer Subsidiary on GMP Violations
April 12, 2013
A recent FDA warning letter chides Italian Pfizer subsidiary Wyeth Lederle for good manufacturing practice (GMP) violations related to investigations into errant endotoxins. The letter cites results from a mid-2012 inspection of Wyeth’s facility in Catania, Italy, noting discrepancies with batches of cancer drug Torisel (temsirolimus).
Drug Industry Daily
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