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US FDA Inspects Natco Pharma Facility; Issues Observations

Summary

  • US FDA inspection at Natco Pharma's Vizag plant concluded recently.
  • The inspection resulted in four procedural observations.
  • Natco Pharma is confident in addressing observations within timelines.
US FDA Inspects Natco Pharma Facility; Issues Observations

A United States Food and Drug Administration (FDA) inspection at Natco Pharma Ltd's Finished Dosage Formulations (FDF) manufacturing plant in Visakhapatnam, Andhra Pradesh, has recently concluded. The inspection took place between August 17 and August 21, 2026, at the facility located in Parawada.

Following the inspection, the company was issued a Form 483, detailing four observations. Natco Pharma has indicated that these observations are procedural in nature. The pharmaceutical company expressed strong confidence in its ability to comprehensively address and resolve all noted observations within the required timelines.

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