A February 17, 2017 FDA warning letter to Wockhardt subsidiary Morton Grove Pharmaceuticals cites numerous cGMP violations, including several related to the manufacture of fluticasone propionate nasal spray. Wockhardt’s generic fluticasone propionate nasal spray was approved by the FDA in January 2012.
The letter states that “During our inspection, we observed that your manufacturing process for fluticasone propionate nasal spray USP relied on an unvalidated and experimental manufacturing process” and says that the company must “provide scientific data supporting the validated status of the fluticasone propionate nasal spray USP manufacturing process” in response to the letter.
According to the letter, when multiple batches of fluticasone propionate nasal spray failed release criteria, the company often retested the product; called the initial failing results “analyst error” without scientific justification; and failed to report the original results. In addition, the company routinely tested in-process samples of the nasal spray and the finished product samples at the same time.
Another violation involved the failure of the company to submit a field alert report (FAR) until more than 6 months after it discovered a batch of fluticasone propionate nasal spray out of specification.
Read the FDA warning letter.
