FDA EIR - Cipla Limited - January 28, 2019

Cipla Limited, located in Vasco Da Gama, Goa, India, underwent a comprehensive surveillance inspection by the U.S. Food and Drug Administration (FDA) from January 21 to January 28, 2019. The inspection was conducted under various compliance programs, including those for pre-approval inspections, animal drug manufacturing, and foreign drug inspections, to assess the facility's adherence to regulatory standards for drug product manufacturing. A prior inspection in September 2018 also resulted in observations, which the firm subsequently addressed, leading to a Voluntary Action Indicated (VAI) classification. During the recent inspection, the FDA issued a Form FDA 483 with six significant observations. These included deficiencies where the quality unit failed to ensure all errors were fully investigated and good aseptic behaviors were not consistently practiced. Furthermore, master production and control records were found to be insufficient, and equipment was not always appropriate for its intended use. Issues also concerned drug product release testing, which was not consistently adequate, and stability study samples not being stored under worst-case conditions. In response, Cipla Limited's management acknowledged the observations, committed to implementing necessary corrections, and agreed to provide a written response to the FDA within 15 business days. The FDA cautioned that failure to make timely corrections could result in further regulatory actions, including a warning letter or import detention. The inspection concluded with a classification of Voluntary Action Indicated (VAI), signifying that while not critical, the identified deficiencies require formal corrective actions.