FDA 483 - Gland Pharma Limited - March 17, 2015

An FDA inspection of Gland Pharma Limited in Hyderabad, India, revealed deficiencies in their quality system. The firm's procedures for annual quality standards record evaluation were found to be inadequate, specifically regarding the tracking and trending of QC laboratory incident reports. Additionally, investigations into unexplained discrepancies lacked complete conclusions and follow-up, including insufficient preventive actions for out-of-specification observations.