Drugs

QS Issues at Mylan Morgantown Plant

A 3/19-4/12 FDA inspection at the Mylan drug manufacturing facility in Morgantown, WV, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 11/9 Warning Letter identifies the violations as:

failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements;
failing 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
failing to follow written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess, and to record and justify any deviations from them.

“Your inspectional history and significant findings in this letter indicate that your quality unit is not fully exercising its authority and/or responsibilities,” the letter says. “Your firm must provide the quality unit with the appropriate authority, sufficient resources, and staff to carry out its responsibilities and consistently ensure drug quality.”

FDA notes that it cited similar CGMP violations at this and other facilities in previous inspections and enforcement actions. It recommends that Mylan engage a qualified independent third-party consultant to assist it in meeting CGMP requirements.

The company was told to correct the violations promptly and to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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