By: IPP Bureau
Last updated : October 30, 2022 9:05 am
The observation is procedural in nature and the company will address the observation within stipulated timelines.
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.