Mylan receives warning from FDA
Flagship plant in Morgantown cited
The U.S. Food and Drug Administration has issued a warning letter to local drugmaker Mylan for “significant violations” of manufacturing regulations at its flagship plant in Morgantown, W.Va.
Among the problems cited in the letter — addressed to Mylan CEO Heather Bresch and dated Nov. 9 — were cross-contamination issues with drug ingredients and “inadequate” investigations of out-of-specification test results.
“Your cleaning validation and verification program for manufacturing equipment is inadequate to prevent cross contamination,” the FDA letter stated. “Your firm has many recurring incidents in which visible drug residues were found on non-dedicated equipment after the equipment was deemed clean by multiple staff.”
Mylan, whose operations base is in Cecil, issued a statement saying, “The issues raised in the warning letter are being addressed.”
“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 company said.
“The Morgantown facility continues to supply products for the U.S. market while we are executing on our commitments to FDA.”
Mylan acknowledged the warning letter Tuesday after FDA Commissioner Scott Gottlieb tweeted about the warning action.
The problems were first outlined in a Form 483 inspection report disclosed on the FDA’s website in June following an inspection at the Morgantown plant from March 19 to April 12.On April 20, Mylan announced that it would lay off about 15 percent of its workforce at the plant in an attempt at “right-sizing” the facility. The restructuring included discontinuing a number of drugs made there and transferring some products to other sites, the company said.
The FDA issued the November warning letter because it found Mylan’s response to the agency’s initial findings described in the Form 483 report “inadequate.”
The letter mentioned similar manufacturing violations
found at other Mylan plants overseas in recent years. “These repeated failures at multiple sites demonstrate that Mylan’s management oversight and control over the manufacture of drugs is inadequate,” the FDA said.
“Because you failed to correct repeat violations, we strongly recommend engaging an independent third party ... to assist your firm in meeting CGMP [current good manufacturing practice] requirements,” the agency said.
The warning letter stated that Mylan had 15 working days to respond by detailing corrective measures.
“Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction,” the letter said.
Separately, Mylan announced a voluntary nationwide recall of certain lots of the high blood-pressure drug valsartan due to trace amounts of an impurity classified as a probable carcinogen.
The recall includes select lots of valsartan and the combination tablets valsartan and amlodipine, and valsartan and hydrochlorothiazide.
The batches were distributed in the U.S. between March 2017 and November 2018.
More details on the recall are available by calling 1-888406-9305.
Regulators worldwide have been cracking down on valsartan-containing products after some were found to contain the suspect substance N-nitrosodiethylamine.