FDA 483 - Apitoria Pharma Private Limited - October 25, 2019

Aurobindo Pharma Limited Unit VIII received an FDA Form 483 following an inspection conducted from October 21 to October 25, 2019. The inspection revealed several significant observations related to the company's manufacturing and quality control processes for Active Pharmaceutical Ingredients (APIs). A key issue identified was the inadequacy of written procedures and validation for equipment cleaning. Specifically, cleaning validation protocols did not comprehensively evaluate all cleaning procedures or cover all relevant equipment parts, and supporting documentation like equipment cleaning logs was incomplete or missing. Furthermore, investigations into critical deviations, such as out-of-specification results for residual solvents and water content in API batches, were found to be insufficiently thorough. These investigations often lacked scientific data to support conclusions and failed to explore all potential root causes, including proper review of equipment qualifications. The Quality Unit's responsibilities and procedures were also cited as not fully established or followed. This included a lack of procedures for determining when reprocessed API batches should undergo stability testing, and an absence of documented rationale for any exclusions. Finally, batch production and control records were noted as incomplete, with critical electronic batch processing data for manufacturing equipment not being properly maintained. Aurobindo Pharma is required to provide a robust response addressing these observations, implementing comprehensive corrective actions to ensure compliance with manufacturing quality standards, and preventing recurrence of these issues.