FDA sends Sanofi warning letter over quality violations
The US Food and Drug Administration has issued a warning letter to French drugmaker Sanofi (Euronext: SAN) following an inspection of its Massachusetts manufacturing site.
The missive raises concerns over “significant deviations” from current good manufacturing practice standards, related to the production of active pharmaceutical ingredients (API).
The facility, acquired through Sanofi's $20 billion purchase of Genzyme in 2011, previously received a Form 483 notice, which outlined preliminary concerns. The FDA has now deemed Sanofi’s response to be inadequate.
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