Miami, FLA “Form 483” is a document issued under the auspices of the US Food and Drug Administration (FDA) over suspected lapses in quality control. In this case, the FDA wrote up Noven Pharmaceuticals for lapses in batch reviews and testing, stability and process controls, and complaints handling. Pundits are left wondering if such lapses have anything to do with Daytrana skin color loss.
The Form 483 issued to Noven by the FDA carried 13 counts.
Noven is the manufacturer of the Daytrana transdermal patch, a product often prescribed to individuals - including children - with attention deficit hyperactivity disorder (ADHD). The Daytrana patch is designed to feed medication in a controlled fashion to the patient through the skin. However, there have been reports of Daytrana skin color loss and other Daytrana side effects associated with the product. While rare, the loss of pigmentation can be permanent. Both the manufacturer and the FDA recommend rotating application sites to avoid impacting the same area of skin and risking skin color loss.
The FDA has warned that such Daytrana skin color loss can be permanent.
According to various reports, the Noven manufacturing facility located in Miami, Florida, was subject to a series of inspections from June 22 through July 10 of this year. Inspectors found various deficiencies. To wit, the accuracy, sensitivity, specificity and reproducibility of test methods were not established and documented. The Form 483 notes that cold flow testing and testing of adhesive transfer were lacking for Noven’s Minivelle, and Daytrana transdermal patches.
When a batch failure has been detected, a manufacturer is required to file an NDA field alert within three working days following notification or discovery that a batch has experienced any kind of failure. The FDA noted that Noven had dropped the ball on this requirement. Written procedures normally produced to ensure that products possess the required identity, strength, quality and purity were lacking.
Any written procedures that did exist were found to lack any requirement for calibration of instruments and apparatus employed in the manufacture of products, at suitable intervals.
As for complaints handling, Noven took heat on that front as well. Since 2006, when the Daytrana transdermal skin patch was launched, Noven has received 41 complaints of Daytrana skin color loss. While requesting a label update, the FDA notes in its Form 483 that Noven failed to undertake any kind of investigation into possible causes of skin pigmentation loss.
Amongst other issues, the FDA noted that Noven initiated a nationwide recall, on July 27, of no fewer than 125,250 Daytrana skin patches due to an adhesive peel force that was out of specification.
Yet another area of concern that may be of interest to any Daytrana lawyer currently handling a case was the finding that an in-house analyst at Noven’s Miami plant, who remained the lone individual undertaking cold flow testing for a two-year period, was inadequately trained.
Are such lapses contributing to Daytrana skin color loss? Any Daytrana attorney handling a Daytrana lawsuit will most certainly be asking that question.
If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a drugs & medical lawyer who may evaluate your Daytrana Patch claim at no cost or obligation.