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Aurobindo's Unit-3 gets Form 483 with six observations

Aurobindo has six formulations manufacturing facilities in India, one each in the US and Brazil.

BS Reporter  |  Hyderabad 

Aurobindo Pharma Limited's formulations manufacturing facility at Bachupally in Hyderabad has received Form 483 with six observations. The US Food and Drug Administration (FDA) had issued the observation letter after conducting an inspection at unit-III during April 10-18, 2017. "The observations are all on procedural improvements. None of them are related to data integrity. The company will be responding as per the prescribed time lines," Aurobindo informed the stock exchanges on Wednesday. The USFDA issues Form 483 to a pharma company at the end of inspection ...

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First Published: Wed, April 19 2017. 16:28 IST
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