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The Factory Floor: Aurobindo Receives Another Form 483

Biocon, Indoco and Lupin Report Successful FDA Inspections

 
• By Akriti Seth

Aurobindo has received further Form 483s from the FDA, while Biocon has received an EIR for its Bengaluru facility. The FDA has also successfully concluded inspections for Indoco and Lupin, while ANI, Aptar and MicroSphere have made strategic moves.

Cogs_Quality_Control
Aurobindo has run-ins with the FDA over quality control measures • Source: Shutterstock

Aurobindo has received further Form 483 observations from the US Food and Drug Administration for two of its manufacturing facilities. Four observations for each facility were received after FDA investigators inspected the firm’s Unit V active pharmaceutical ingredient manufacturing facility at Pashamylaram, Hyderabad from 21-28 October 2019, and its Unit VIII, API manufacturing facility at Gaddapotharam, Hyderabad of the Company from 21-25 October 2019. Meanwhile, an inspection at Aurobindo’s Unit IV formulation manufacturing facility at Pashamylaram is in progress.

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