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USFDA issues Form 483 for Parawada unit of Laurus Labs

The observation is procedural in nature and the company will address the observation within stipulated timelines.

  • By IPP Bureau | October 30, 2022

The US Food and Drug Administration (USFDA) has completed a Pre- Approval Inspection (PAI) at Laurus Labs Limited manufacturing facility at Unit-5, Parawada, Visakhapatnam, Andhra Pradesh.

The inspection was conducted from 24-28th October 2022 and the company has been issued a Form 483 with one observation. The observation is procedural in nature and the company will address the observation within stipulated timelines.

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