Natco Pharma gets 6 observations from USFDA for API Facility

At the end of the inspection, the Mekaguda facility, near Hyderabad received six observations mostly procedural in nature.

Aug 13, 2019 03:08 IST India Infoline News Service

Natco Pharma announced on August 12, 2019 that the regulatory inspection from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) facility in Mekaguda Village, near Hyderabad, India, has been completed, which was conducted during the period August 05, 2019 to August, 09, 2019.

At the end of the inspection, the facility received six observations 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.

Key points of the observations in Form 483 outlined below:
  • Supplier & service provider agreements to be made more robust. Some procedural improvements in gowning section recommended.
  • Employees engaged in the manufacturing and packaging areas require more effective training.
  • Procedural improvements needed in process revalidation protocols and approval of alternate supplier sources.
  • Visual stains were observed in some early stage reactors that need further diagnosis and improvement. ‘Status tags’ for certain drying process equipment were not to be found.
  • Incident report not raised for software systemic error found in Karl-Fisher instrument in the QC lab.
  • Procedural and handling gaps found in settling plate management in the microbiology lab.
  • The company will provide due justifications and corrective action plan within the next 15 working days to address the above USFDA observations.

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