Natco Pharma Ltd has announced the completion of a regulatory inspection from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) facility in Mekaguda Village near Hyderabad.
The inspection was conducted during August 5-9, and the facility received six observations mostly procedural in nature, the company stated.
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 include Supplier and service provider agreements to be made more robust, some procedural improvements in gowning section were recommended, employees engaged in the manufacturing and packaging areas require more effective training and procedural improvements needed in process revalidation protocols and approval of alternate supplier sources.
Other observations include 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.
There were also observations relating to procedural and handling gaps found in settling plate management in the microbiology lab.
The company said “It will provide due justifications and corrective action plan within the next 15 working days to address these USFDA observations.”