FDA 483 - Goran Pharma Private Ltd - November 15, 2017

An FDA inspection of Goran Pharma Pvt Ltd in Sihor, India, revealed numerous significant deficiencies in their drug manufacturing operations. The firm lacked adequate microbiology laboratory facilities, failed to ensure proper personnel gowning, and did not consistently follow or establish written procedures for quality control, annual product reviews, and cGMP training. Critical issues were also identified in equipment maintenance, labeling control, water system integrity, supplier qualification, product release testing, and the overall stability study program for their drug products.