- Citing repeat manufacturing violations, the Food and Drug Administration has issued a warning letter to Mylan regarding a production facility in India.
- The complete response letter (CRL), dated April 3, 2017, and posted on the agency's website Tuesday, called out Mylan for data and quality control violations at the facility, located in the city of Malegaon Taluka.
- The agency was most critical, however, of the generic drugmaker essentially using Band-Aids to treat deep wounds. While the company made attempts to improve its manufacturing processes, it didn't conduct thorough investigations to get to the root of problems.
Mylan's CRL fits into two larger trends: the steady drip of setbacks for the generics maker and the widespread manufacturing issues at Indian pharmaceutical sites.
Mylan has had a rough 2017 so far. Late last month, Pfizer's subsidiary Meridian Medical Technologies, which produces Mylan's EpiPen, extended a voluntary recall for the epinephrine autoinjectors to the U.S. The recall had already been in place for other countries, including Australia, Japan and New Zealand.
That announcement came right on the heels of the company's decision to shutter an Illinois-based manufacturing plant, axing 90 jobs in the process, as well as the FDA's first-pass rejection of its generic copy of GlaxoSmithKline's Advair (fluticasone/salmeterol).
While Mylan will likely correct the problems with the Advair copycat's application, company shares have continued to slide since the FDA's decision.
On the bright side, Mylan did recently reach a settlement with Roche allowing it to market a biosimilar to Herceptin (trastuzumab) outside of Brazil, Japan and Mexico, clearing the way for future commercialization.
Regarding the warning letter, the FDA cited the plant for data integrity and quality control problems — issues that have bedeviled Indian manufacturers struggling to comply with the FDA' stepped-up oversight of foreign drugmakers.
"Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture," the agency wrote in the letter.