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The Quality Lowdown: Cleaning Issues At Mylan, Blank Release Forms At API Plant In China, And More

 
• By Bowman Cox

Mylan can look forward to mopping up some major cleaning validation issues a large team from FDA found during an extensive inspection of the firm’s West Virginia plant. Meanwhile, an API firm in China found it should not have left blank product release forms lying around pre-stamped “Permitted to Leave Factory.”

The referee gave a red card for the player in stadium

When an eight-person team inspects a pharmaceutical manufacturing plant, it will be likely to observe all kinds of problems, and that certainly was the case with a massive Form 483 report that surfaced on FDA’s web site last week after a major inspection of Mylan’s plant in West Virginia.

Meanwhile, an active pharmaceutical manufacturing plant in China was found to have data integrity issues deserving of a warning letter,...

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