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Volume 20 No 6 (2022)
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Retrospective Analysis of USFDA Warning letters against cGMP Violations in Indian Pharmaceutical Industries
Dr. Raju Kamaraj, T.Sudheer Kumar
Abstract
Background: The Indian pharmaceutical industry is a leading supplier of generic drugs to the United States and is prospering rapidly. USFDA is stringent towards the quality of the medicines supplied to the US. USFDA inspects its manufacturing sites regularly to check for compliance with regulations.Observations were notified in the form of Form 483 and Warning Letters ask for Justifications &
Corrective actions for those observations within the stipulated period
Keywords
cGMP, Warning Letters, USFDA, India
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