Natco Pharma API plant hit with Form 483

Aug 12, 2019

Natco Pharma has received a Form 483 with six observations from the U.S. FDA for the drugmaker's active pharmaceutical ingredient facility located outside Hyderabad, India.

The FDA conducted the inspection at the Mekaguda Village facility between August 5-9, 2019. According the Natco's regulatory filling, the facility received six observations that are "mostly procedural in nature. The company believes that none of observations are related to data integrity and that all the observations can be addressed within a short period of time."

The FDA observed procedural and handling gaps in the microbiology lab and noted that employees engaged in the manufacturing and packaging areas required more effective training. Natco says it will provide due justifications and a corrective action plan within the next 15 working days to address the FDA observations.

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