MORGANTOWN — Mylan continues to work on remediation of issues at its Morgantown plant. It addressed the issues at the Morgantown plant in its third-quarter earnings report issued earlier this month, and in a recent press release issued in response to a U.S. Food and Drug Administration warning letter sent to Mylan on Nov. 9.
“These activities are already reflected in our 2018 outlook, and the issues raised in the warning letter are being addressed within the context of this plan,” Mylan said in the release. “We have been in regular communication with FDA and will continue to work to ensure that the agency is satisfied with the steps we have taken to resolve all the points raised in the warning letter.”
The Dominion Post reported in June that Mylan’s Morgantown plant underwent an FDA inspection from March 19 through April 12 that led to a report listing conditions that may constitute violations of the Food Drug & Cosmetic Act and related acts.
The FDA listed 13 observations, with explanatory details, in a 32-page Form 483 that it presented to Mylan. The company then submitted to the FDA what it termed a “comprehensive response and robust improvement plan.”
In its Nov. 9 warning letter, the FDA revisited some of the issues, which it regards as “significant violations of current good manufacturing practice (CGMP is its acronym) regulations and Mylan’s response to them.
The FDA urges prompt correction of the violations and says failure to do so could result in legal action, seizure, injunctions, loss of access to federal contracts and withholding of approval of pending drug applications.
In its response to the FDA letter and in its earnings report, Mylan said it has discontinued production of some products at the Morgantown site and transferred production of some to other sites.
“These actions have led to a temporary disruption in supply of certain Mylan products for customers,” Mylan said. “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.”
In its warning letter, the FDA said inspectors observed issues with equipment cleaning and sanitization, opening the possibility of product cross contamination; inadequate investigation of tests indicating out-of-specification products; failure to follow procedures to assure consistent product strength, quality and purity.
FDA also said the plant’s quality unit is not fully exercising its responsibilities and its quality systems are inadequate.
In its response, Mylan said, “We have an industry-leading track record in global quality management, and we take very seriously our continued and comprehensive oversight of Mylan’s entire manufacturing network. We continuously learn from inspections of our facilities by FDA and other authorities as regulatory expectations continue to evolve.
It continued, “When we have received FDA warning letters in the past we have worked comprehensively and closely with FDA to address the issues raised and each of those prior letters was successfully resolved. The Nov. 9 Morgantown letter is the sole outstanding FDA Warning Letter to Mylan. We will apply the same rigor and focus to our work with FDA regarding its observations of our manufacturing facility in Morgantown, which remains an important part of Mylan’s global manufacturing network.”
Mylan layoffs
In its third quarter report, Mylan also noted that the Morgantown plant’s restructuring and remediation program includes workforce reduction.
Sources familiar with the process explained that the restructuring portion of the program is actually separate from the remediation undertaken in response to the FDA inspection.
Mylan first announced a global restructuring in December 2016 that would involve trimming somewhat less than 10 percent of its global workforce.
Related to this restructuring, Mylan announced last April that it was reducing its Morgantown workforce by about 15 percent, from about 3,500 workers to 3,000. The action affected about 400 union workers.
That April announcement just happened to coincide with the FDA inspection.
Mylan said at the time, “We believe our plant in Morgantown is one of the largest pharmaceutical manufacturing facilities in the world. As the industry has changed and regulatory expectations have continued to evolve, we’ve realized that our Morgantown plant needed to be rightsized to be less complex.”
It continued, “The right-sizing is consistent with discussions we are having with the FDA and is necessary in order to position the site as best we can for continued operations.”
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