FDA 483 - Torrent Pharmaceuticals Limited - September 28, 2022

During an inspection conducted from September 19-28, 2022, the U.S. Food and Drug Administration (FDA) identified significant objectionable conditions at Torrnets Pharmaceuticals Limited in India. The inspection revealed critical deficiencies primarily related to Current Good Manufacturing Practice (CGMP) regulations for pharmaceutical manufacturing. A primary concern was inadequate cleaning and maintenance of equipment. Inspectors observed visible product residues (powder, flakes, thread-like material) on manufacturing equipment tagged as "CLEANED." The firm's manual cleaning procedures and analytical methods for verifying cleaning effectiveness were found to be insufficient, with cleaning validation studies lacking worst-case scenario assessments. Furthermore, equipment damage, such as dents, was noted but not adequately identified or addressed by the company. Another major issue involved a systemic failure in laboratory investigations. The company routinely consolidated out-of-specification (OOS) results and laboratory incidents without thorough root cause analysis, particularly concerning cleaning-related contamination. Test results were often invalidated without scientific justification, and subsequent re-tests were reported as the official record. External evaluations also indicated that amended investigation reports lacked clear, unequivocal root causes. Finally, the FDA cited deficiencies in the firm's handling of product quality complaints. Investigations were hampered by a lack of batch details and the failure to analyze returned samples, contrary to internal procedures and third-party recommendations. There were also notable delays in conducting medical assessments for contamination complaints (over six months in one instance) and in submitting Field Alert Reports. Torrnets Pharmaceuticals Limited is required to provide a comprehensive written response to the FDA within 15 working days, detailing corrective and preventive actions to address these serious violations and ensure compliance with federal regulations, thereby safeguarding drug product quality and patient safety.