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Tag Archives: finished drug products
Apotex Research Private Limited, Bangalore, India Receives Warning Letter (1/30/15)
During a June 23, 2014 through July 1, 2014, inspection of the Apotex Research Private Limited (ARPL) manufacturing facilities located at Plot #1 & 2, Bommasandra Ind. Area, 4th Phase, Jigani Link Road, Bangalore, India, investigators from the U.S. Food and Drug Administration … Continue reading
Posted in FDA Compliance, Microbiological Issues, Regulatory Compliance, Warning Letters
Tagged 211.113(a), data falsification, finished drug products, in-process products, in-process testing, media growth promotion, microbiological test plates, microbiological tubes, Risk Assessment, water
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