FDA 483 - Zenara Pharma Pvt Ltd - May 21, 2024

Zenara Pharma Pvt Ltd, a drug manufacturer in Hyderabad, India, was cited for significant deficiencies in its quality systems. Observations included inadequate production and process controls, poorly designed manufacturing equipment leading to yield issues, and a lack of proficiency in data integrity audit trail reviews. The inspection also noted insufficient investigation into out-of-specification dissolution results.