A US District Court has ordered Wockhardt subsidiary Morton Grove Pharmaceuticals “to stop manufacturing and distributing drugs alleged to be adulterated.” The Morton Grove facility manufactured fluticasone propionate nasal sprays in addition to other products. The company has signed a consent decree agreeing to cease production, to destroy already manufactured drugs, and to hire an independent cGMP consultant to inspect the facility and submit the results to the FDA.
The US Department of Justice alleges that, “the company violated the FDCA by failing to have adequate procedures to prevent cross-contamination of equipment, failing to reject drug lots using a contaminated ingredient, and failing to fully investigate the root cause of such contamination. The department also alleged the Food and Drug Administration (FDA) inspected the company’s facility five times, in 2011, 2014, 2016, 2019, and 2021, and that many of the violations were repeat violations the FDA had identified in earlier inspections.”
Wockhardt’s ANDA for its generic version of Flonase fluticasone propionate nasal spray was approved in 2012, and the company launched the nasal spray in the US that same year. In 2017, the FDA issued a warning letter to Morton Grove Pharmaceuticals stating that the “manufacturing process for fluticasone propionate nasal spray USP relied on an unvalidated and experimental manufacturing process” and failed to properly deal with nasal spray batches that failed release criteria.
Read the US Department of Justice press release.
