USFDA issues Form 483 for Parawada unit of Laurus Labs
Drug Approval

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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