FDA 483 - Naari Pharma Private Limited - January 27, 2023

Nasri Pharma Private Limited, a drug product manufacturer, was cited for significant deficiencies in its production and process controls. Observations included failures to record deviations in process validation reports and a lack of adequate written procedures to ensure drug product quality, purity, and strength. The firm also exhibited issues with following SOPs, inconsistent batch record entries, and inadequate investigations into out-of-specification results.