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Generic Drug Manufacturing Issues Draw FDA Warning Letters at Sandoz and Mylan

Jan 3rd, 2012

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Oral solid manufacturing drew FDA warning letters in the fourth quarter of 2011 at two of the largest generic companies – Sandoz and Mylan.  Injectable production was also implicated in the warning letter received by Sandoz.

The Sandoz letter – addressed to its Basel, Switzerland-based parent company Novartis in mid-November – is more extensive in its scope, stretching across the firm’s two US solid oral dosage manufacturing facilities located in Broomfield, Colorado, and Wilson, North Carolina and a Boucherville, Quebec, Canada site that manufactures injectables.  The letter covers inspections that took place at the facilities in the US and Canada between April and August of 2011.

FDA emphasized that there were “multiple repeat observations” at all three Sandoz sites from their most recent inspections, in particular in the areas of equipment interchangeability and maintenance and process variability.  In the case of the Wilson, North Carolina facility, these areas 0f concern were highlighted in a 2008 warning letter addressing GMP issues at that plant.

Mylan’s letter was issued in mid-October and addressed a four-week inspection at it Caguas, Puerto Rico facility that began in late January.  Pittsburg’s Tribune-Review reported that this was the first FDA warning letter the company has received in its 50-year history and that it should not have a significant impact on Mylan’s finances or new product approvals (link provided below).  Mylan is located in Canonsburg, just outside Pittsburgh.

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