In November last year, USFDA had issued Form-483 with eight observations each for product and raw material production centres at Lupin's Mandideep-based manufacturing facility. As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
from Top Health News | Latest Health & Healthcare Industry Information and Updates: ET HealthWorld : ETHealthworld.com https://ift.tt/fLCeoWG
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» USFDA issues Form-483 with 10 observations to Lupin's Pithampur plant
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