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Granules’ Form 483: Trucks Full Of Documents, Deficient Maintenance, And Bird Droppings

The Inspection Was Carried Out From 26 August To 6 September

 
• By Urtė Fultinavičiūtė

The US FDA has issued a Form 483 to Granules India, with six observations, spanning document and vent mismanagement to bird droppings and rust.

Magnifying glass showing a question mark
• Source: Shutterstock

“Manufacturing excellence, process innovation, and regulatory expertise” are some of the statements made by the generics manufacturing firm Granules India on its website, but the recent six observations noted in the US Food and Drug Administration’s Form 483 might contradict them.

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