USFDA issues Form 483 to Alembic Pharma Gujarat plant

Alembic Pharma gets Form 483 from USFDA

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USFDA
Picture: Pixabay

Last Updated on December 18, 2021 by The Health Master

US Food and Drug Administration (USFDA) issued a Form 483 for Alembic Pharma’s Karkahadi plant in Gujarat.

10 observations on Form 483 issued by the US regulator after its inspection at Alembic Pharma from October 28-November 10.

The regulator largely observed that the plant had not established control procedures and processes with respect to cleaning and maintenance were inadequate.

The USFDA also said the procedures to prevent microbiological contamination were inadequate and that the plant did not maintain written records of investigations into unexplained discrepancies.

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