Dive Brief:
- Following an inspection of Noven Pharmaceuticals Inc.'s Miami manufacturing facility, the Food and Drug Administration has closed out the warning letter it issued the company in 2016.
- To resolve the FDA's concerns, Noven carried out what it described as a "comprehensive remediation program" covering all of its quality systems to bring the plant up to current Good Manufacturing Practice standards.
- In the 2016 letter, FDA inspectors flagged an increase in complaints about transdermal patches made by Noven, including an estrogen therapy for menopausal women.
Dive Insight:
The warning letter for Noven's Miami drug manufacturing site was issued back in August 2016, following a 2015 inspection which revealed "significant violations of current Good Manufacturing Practice regulations for finished pharmaceuticals." In the letter, FDA officials raised a concern that these violations were masking product failures.
According to the FDA, complaints for Noven's Minivell transdermal patch increased by 50% between 2013 and 2014, while a significant share of complaints for another patch sold as Daytrana involved an issue Noven hadn't detected as a problem.
Violations included failing to establish and document the accuracy, sensitivity, specificity and reproducibility of test methods; failing to record and justify deviations from test procedures; failing to investigate discrepancies in products; failing to maintain written records; and failing to follow up complaints correctly.
Since then, Noven said it has carried out a company-wide overhaul of its quality systems.
"For more than two years now, we have been focused on creating a robust and sustainable quality program based on a culture of quality, accountability across the entire organization and the continuous improvement of our people, processes and products," said Noven CEO Jeff Mihm.
The FDA agreed, issuing the close-out letter to Noven that clears the plant of the warning letter overhang.