FDA 483 - Jubilant Pharmova Limited - October 27, 2017

This FDA Form 483 report details significant quality control deficiencies at Jubilant Generics Limited, an API manufacturer in Nanjangud, India. Observations include the failure to recall APIs that failed stability testing, inadequate investigation of customer complaints, and poor maintenance of facilities and equipment leading to contamination risks. Additionally, the firm lacked assurance that shipped APIs were protected from harsh environmental conditions due to unmonitored storage.