Home » API Maker Warned for Failing to Act on Contamination
API Maker Warned for Failing to Act on Contamination
A French active pharmaceutical ingredient (API)
maker received a warning letter for
failing to take appropriate action on API lots shipped to the U.S. that may be affected by a cross-contamination problem. Although Zach System, based in
Avrille Cedex, France, discovered the cross-contamination in March 2008, it did not notify customers until after a June FDA inspection, and its investigation
has not defined the extent of the contamination, according to the Oct. 23 letter posted last week to the FDA website.
Drug Industry Daily
Drug Industry Daily
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