FDA Issues Warning Letter to Mylan for Pharma Manufacturing Facility

In a warning letter issued to Mylan, FDA cited violations of good manufacturing practice (CGMP) regulations for finished pharmaceuticals at Mylan’s Morgantown, WV, manufacturing plant based on an inspection conducted from March 19, 2018 to April 12, 2018.

The letter, dated Nov. 9, 2018, pointed out that the “methods, facilities, or controls for manufacturing, processing, packing, or holding” did not conform to CGMP and that drug products made there were adulterated. FDA observed that the company failed to: maintain a clean and sterile environment; investigate unexplained discrepancies or batch failures; and follow written protocols. The agency requires the company to include a validated cleaning program, an independent evaluation of a change management system, and an assessment of manufacturing-operation reliability, among other things, in its response to the warning letter.

In a statement issued on Nov. 20, 2018 to the warning letter, Mylan stated that it has implemented a comprehensive restructuring and remediation plan at the Morgantown plant and has been in regular communication with FDA to resolve all points raised in the letter.

Mylan also stated that the Morgantown facility continues to supply products for the US market and does not expect to have any significant new product launches from that site in 2019. As part of the ongoing restructuring and remediation activities, the company has discontinued a number of products from the site while also transferring some products to other sites, which has led to a temporary disruption in supply of certain Mylan products.

“We understand that this current and temporary situation puts a burden on our customers and appreciate their ongoing confidence in Mylan. We will continue to work closely with our customers to mitigate any possible supply disruptions and meet the needs of the patients we serve,” the company said in its statement.

Source: FDA, Mylan