The FDA recently issued another warning letter to Noven, a standalone operating subsidiary of Japan-based Hisamitsu Pharmaceuticals, for lapses at its Miami production facility.
In the warning letter dated Aug. 5, the regulatory agency cited infractions in batch reviews and testing, stability and process controls and complaint handling at the facility as a result of an inspection conducted by the agency in July of 2015.
In its latest warning, the FDA said that due to operating procedures found during the inspection that the company does not conform to CGMP regulations and the products are considered “adulterated” under the Federal Food, Drug, and Cosmetic Act.
Noven began recalling tens of thousands of boxes of its Daytrana patches from the market because of issues over peeling away a protective liner to deliver the ADHD drug. The recall, which began last summer, has resulted in a shortage of the patches.
The company said the patches were recalled because they were out of spec for their mechanical peel force and z-statistic value, which it said was directly related to a patient’s or caregiver’s ability to remove the release liner from the patch adhesive before it is applied to the skin.
The patches were manufactured at the Miami facility and were approved for children and adolescents.
Noven has previously been hit with two FDA warning letters, one in 2008 and one in 2011, which was only a couple of years after Hisamitsu shelled out $430 million to buy the company.
- check out the FDA warning letter