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Mylan's Morgantown plant receives FDA warning letter

Published on 21/11/18 at 10:20am

Generic drugmaker Mylan has received a warning letter from the FDA over concerns surrounding the firm’s manufacturing plant in West Virginia.

The letter, dated November 9th, has come in response to an inspection of Mylan’s Morgantown, West Virginia manufacturing plant in April of this year.

The letter warns that Mylan had failed to “clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment”; the company had “failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed”; and that they had “failed to follow written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and to record and justify any deviations from them”.

Prior to receiving the letter Mylan had had a “pristine” regulatory track record. The letter signifies Mylan’s Morgantown plant’s first warning letter since the facility was opened in 1996.

“It is unclear how long the issues will take to resolve and even what the immediate upside impact could be ... (still) management indicated that none of its key expected new product launches during 2019 were filed from the Morgantown facility,” Raymond James analyst Elliot Wilbur said.

Louis Goss

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