FDA Warning Letter to Noven Pharmaceuticals

August 19, 2016
Pharmaceutical Technology
Pharmaceutical Executive

August 19, 2016

FDA has issued a Warning Letter to Noven Pharmaceuticals, Inc. (Miami, FL) pointing to a number of problems with measurement, analysis and testing, as well as insufficient attention to customer complaints and their root causes.  

Customer complaints for one product reportedly increased by 50% from 2013 to 2014, inspectors noted, but Noven had failed to determine the root causes of problems.  Inspectors trace that to inadequate testing methods.  

Noven’s staff members had also failed to validate test methods to detect adhesive transfer, FDA said, which would remove the drug from the product, rendering it unusable.