FDA CItes Measurement, Validation Deficiencies in its Warning Letter to Noven

FDA has issued a Warning Letter to Noven Pharmaceuticals, Inc. pointing to a number of problems with measurement, analysis and testing, as well as insufficient attention to customer complaints and their root causes.  Inspectors took exception to one particular measurement method used to measure movement of adhesive past the edges or through the slit in a release liner, calling it “unsound,” and noting that movement of adhesive can lead to product detachment and expose the drug to other people.

Customer complaints for one product 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.  In one case, subjective visual interpretation was used to determine whether adhesive residue remained on a pouch or around product edges.  Another test required excessive sample handling, which, inspectors said, could result in inaccuracy. The company had told FDA inspectors previously that it would assess testing methods, yet continued to use those same methods for release testing.

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. 

Inspectors also found that analysts failed to follow the firm’s testing procedures.  In one case, the analyst did not record failed tests.  In another, the analyst did not calibrate the testing machine.  The company had also failed to investigate discrepancies of batch failures.

Noven was also cited for failing to maintain written records so that data could be used to evaluate quality standards, and for failure to follow written procedures for handling all written and oral complaints, a problem that FDA had noted at the facility in February, 2009.