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US FDA nod to Laurus Labs

12th July 2019

The Laurus Labs has successfully completed the US FDA audit of their Visakhapatnam’s Unit 4 facility without any Form 483. The audit was done between 8 July – 12 July 2019.

The Unit-4 is involved in the Active Pharmaceutical Ingredient manufacturing.

The form 483 is notified to the management of company regarding objectionable conditions. Since the Laurus Labs did not get any Form 483 for its active pharmaceutical ingredient manufacturing plant based at Visakhapatnam, it reveals that the inspectors did not observe any violations of the Food Drug and Cosmetic Act and related acts.

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