FDA Warns Drug Ingredient Maker Over Testing Issues

Law360, New York (August 20, 2013, 3:30 PM EDT) -- Indian drug component manufacturer Posh Chemicals Pvt. Ltd. must address several documentation and quality-control issues or risk losing U.S. Food and Drug and Administration approval for its products and products made with its ingredients, according to an FDA missive made public Tuesday.

According to the FDA warning letter, dated Aug. 2 but not publicly released until Tuesday, an inspection of Posh’s manufacturing facility in Jeedimetla, India, had turned up several “significant” deviations from so-called current good manufacturing practice, or CGMP, for active pharmaceutical ingredients, or APIs,...
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