Natco Pharma Limited announced the conclusion of a U.S. Food and Drug Administration (FDA) inspection at its Finished Dosage Formulations (FDF) unit in Visakhapatnam, Andhra Pradesh. The inspection, conducted from August 17th to August 21st, 2026, resulted in the issuance of 4 observations. The company stated that these observations are procedural in nature and expressed confidence in addressing them comprehensively within the stipulated timelines.
US FDA Inspection Concludes at Visakhapatnam Facility
NATCO Pharma Limited has officially announced the completion of an inspection by the U.S. Food and Drug Administration (FDA) at its manufacturing facility located in Visakhapatnam, Andhra Pradesh. The unit in question is the company’s Finished Dosage Formulations (FDF) plant.
Inspection Details and Outcome
The FDA inspection took place from August 17th to August 21st, 2026. Upon the conclusion of the inspection process, the company reported that it was issued a Form 483, which included 4 (Four) observations. NATCO Pharma has indicated that it believes these observations are procedural in nature.
Company’s Response and Outlook
NATCO Pharma Limited expressed confidence in its ability to comprehensively address these observations within the required timelines. The company has provided this update for the information and records of its stakeholders. The Visakhapatnam facility is a key manufacturing site for the company’s pharmaceutical products.
Source: BSE
