FDA 483 - Gelnova Laboratories (India) Private Ltd. - February 01, 2019

Geinova Laboratories Pvt. Ltd. in Navi Mumbai, India, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in laboratory controls, batch production records, cleaning procedures, and equipment maintenance, particularly concerning the testing and release of drug products and calibration of critical equipment. These issues indicate a lack of adherence to good manufacturing practices that could impact product quality and safety.