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Dr Reddy's SEZ unit completes USFDA inspection for second time

US drug regulator audited company's API manufacturing unit at the same plant in April

BS Reporter  |  Hyderabad 

reddy, dr reddy's

Hyderabad-based Dr Reddy's Laboratories informed the stock exchanges that the US Food and Drug Administration (USFDA) has completed the audit of its formulations at unit II in Srikakulum's special economic zone (SEZ) in on Thursday.

According to the compnay, the has made no observations after the inspection. 

In April, the US drug regulator had inspected Dr Reddy's active pharmaceutical ingredients (APIs) manufacturing unit at the same in Srikakulam with no observations. After the inspection of yet another API facility at Srikakulam in the month of April, the had issued Form 483 after making two observations.

The issues Form 483 to a pharma company when it finds the firm guilty of violating the Food Drug and Cosmetic Act. The company should respond to the Form 483 with a corrective action plan and then implement it on an immediate basis.

 

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