Indian drug manufacturer Natco Pharma received the Form 483 following an inspection by the US Food and Drug Administration (FDA) at its active pharmaceutical ingredient (API) facility in Mekaguda Village, near Hyderabad, India, by August 5 to August 9, 2019.
According to Natco, the observations were related to the following issues:
• 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.
Natco stated that the observations as “mostly procedural in nature”, adding that none of them are related to data integrity and that all can be addressed within a short period of time.
The company also stated that it will provide justifications and corrective action plan within the next 15 days to address the observations.
The Mekaguda plant is good manufacturing practice (GMP) compliant and has a capacity of 398 KL.
Natco previously received a Form 483 with six observations regarding its formulations facility in Kothun village near Talangana, India, following an inspection in January 2017.