Aurobindo Pharma Limited – FDA 483, Sep 27, 2019

During an FDA inspection from September 19-27, 2019, Aurobindo Pharma Limited's Unit VII formulation plant in Polepally, India, received a Form FDA 483 detailing significant manufacturing quality and control deficiencies. Observations revealed a systemic failure to thoroughly investigate unexplained discrepancies and Out-of-Specification (OOS) results. The firm frequently attributed OOS issues to human or instrument error, validating initial failing results based on unverified hypothesis studies or without scientifically sound root causes, allowing potentially non-conforming products to reach the U.S. market. Furthermore, product complaint investigations were inadequate; for instance, numerous broken tablet complaints were dismissed as post-manufacturing issues despite internal records showing re-inspection and repackaging of rejected units without proper documentation. Data integrity concerns arose from incomplete laboratory records, unreviewed audit trails showing frequent instrument errors, and the use of an uncontrolled logbook for OOS entries. The inspection also cited a lack of robust production and process controls, including the use of unlisted batch records, poor control over document re-issuance, and deficient commercial process validation where many batches failed. Equipment was found unclean with residue in inaccessible areas after cleaning, posing a contamination risk. Finally, the quality control unit exhibited procedural non-compliance, providing inconsistent information, maintaining unsigned investigation reports listed as closed, and releasing products to the U.S. market with incomplete batch records lacking final quality assurance approval. These observations indicate significant deviations from current Good Manufacturing Practices (CGMP) and require comprehensive corrective actions from the company.