On November 9, 2018, the US Food and Drug Administration (FDA) issued the company a warning letter related to observations made in April, 2018, at its manufacturing facility in Morgantown, West Virginia
Mylan initially received a Form 483 that included thirteen observations at the Morgantown plant, which was followed by the warning letter.
The company made a statement on November 20, 2018, in regard to the warning letter. In the statement, Mylan said that the company has implemented “comprehensive restructuring and remediation” at its Morgantown facility.
Mylan said that the issues raised in the warning letter are being addressed within the context of the company’s implementation plan. It also stated that the company has been in communication with the FDA since the warning letter was received.
The Morgantown facility supplies products for the US market and has continued to do so while it has worked to implement its plan of action. However, as part of the restructuring and remediation, Mylan discontinued a number of products from the site, transferring products to other facilities. There has since been a temporary disruption to the supply of certain products.
In April, when the Form 483 was issued, Mylan announced it had plans to lay off roughly 15% of its employees in Morgantown. At the time, a Mylan spokesperson told us, “As the industry has changed and regulatory expectation continued to evolve, we’ve realized that our Morgantown plant needed to be right-sized to be less complex.”
Suspension and recall
On November 20, 2018 however, the company initiated a voluntary nationwide recall of 15 lots of valsartan tablets.
N-nitrosodiethlamine (NDEA) was found in some batches of Mylan’s valsartan which prompted the decision to voluntarily recall nationwide and to suspend use in the EU. NDEA is classified as a probable carcinogen.