Noven Pharmaceuticals Hit With 13-Item Form 483

The FDA handed Noven Pharmaceuticals a 13-item Form 483 for lapses in batch reviews and testing, stability and process controls and complaint handling.

During the June 22 to July 10 inspection of the transdermal patch maker’s Miami, Fla., facility, investigators found that the accuracy, sensitivity, specificity and reproducibility of test methods were not established and documented. Cold flow testing and testing of adhesive transfer were lacking for the company’s Minivelle and Daytrana TDS patches, the 483 says.

Noven’s written procedures didn’t require calibration of instruments and apparatus at suitable intervals, and the firm failed to review unexplained discrepancies and batch failures.

The drugmaker also failed to file an NDA field alert report within three working days of receiving information about batch failures, and there were no written procedures to assure products have the proper identity, strength, quality and purity, the 483 says.

The FDA also dinged Noven’s complaint handling practices. Since launching Daytrana for attention deficit hyperactivity disorder in 2006, the company has received 41 complaints of skin pigmentation, leading it to request a product labeling update, but the firm never conducted an investigation into a possible cause, the 483 says.

Additionally, Noven’s call center failed to request that samples be returned to investigate complaints, and the firm never tested retained samples when complaints exceeded the alert limit.

Noven initiated a nationwide recall of 125,250 Daytrana patches on July 27 due to an out-of-specification adhesive peel force, according to an Oct. 14 FDA enforcement report.

Finally, investigators found that employees weren’t retrained when SOPs required it. For example, an in-house analyst, who was the only employee to perform cold flow testing for more than two years, didn’t appear to be adequately trained, the 483 says.

Noven Pharmaceuticals did not return a request for comment by press time. View the Form 483 at www.fdanews.com/10-20-15-Noven483.pdf. — Kellen Owings