FDA 483 - Zenara Pharma Pvt Ltd - January 20, 2023

Zenara Pharma Private Limited, a finished drug product manufacturer in Hyderabad, India, received a Form 483 with two observations. The inspection revealed significant deficiencies in the firm's written procedures for equipment cleaning and maintenance, specifically concerning the analytical methods used to detect residual drug product carryover. These issues indicate a lack of assurance in the effectiveness of cleaning processes and the accuracy of residue detection.