Gets issued two Form 483 observations
Granules India announced that its subsidiary, Granules Pharmaceuticals ,Inc. has completed USFDA inspection of its facility located at Chantilly, Virginia, USA from 22 October 2018 to 26 October 2018 with two Form 483 observations.Granules Pharmaceuticals, Inc. will respond to the observations within this week. This was a prior approval inspection, intended for the ANDAs filed by Granules Pharmaceuticals, Inc. This facility is involved in development and manufacturing of Finished Dosages.
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