NATCO Pharma’s Visakhapatnam facility receives 4 observations in US FDA inspection

The company said it believes the observations are procedural in nature and expressed confidence that it will address them comprehensively within the stipulated timelines

NATCO Pharma said the US Food and Drug Administration (FDA) has concluded an inspection of its finished dosage formulations (FDF) manufacturing facility at Parawada, Visakhapatnam, Andhra Pradesh.

The inspection was conducted from August 17 to August 21, 2026. Following the inspection, the company was issued a Form 483 containing four observations.

NATCO Pharma said it believes the observations are procedural in nature and expressed confidence that it will address them comprehensively within the stipulated timelines.

The company disclosed the development pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.