FDA 483 - Cipla, Ltd. - November 30, 2018

An FDA inspection of Cipla, Ltd. in Kurkumbh Village, India, from November 26-30, 2018, revealed significant deficiencies in the firm's manufacturing practices. Observations included a failure to follow written procedures for equipment cleaning validation and a pervasive lack of raw data evidence for critical production and process control parameters. These issues indicate serious concerns regarding data integrity and adherence to established quality standards.