FDA 483 - Lupin Limited - November 23, 2022

This FDA Form 483 documents multiple observations from an inspection, indicating significant deficiencies in the facility's quality system and manufacturing operations.

Key violations include: * **Inadequate investigations:** Failure to thoroughly review unexplained discrepancies, batch failures, or out-of-specification results, including root cause determination for API/intermediate failures. * **Data integrity and computer system controls:** Lack of appropriate controls over computer systems to ensure changes to master production/control records are by authorized personnel, and insufficient controls to prevent unauthorized access or data changes. * **Documentation and recordkeeping:** Failure to maintain production, control, distribution, component, and labeling records for at least one year past expiration. Written procedures for annual batch record evaluations are not established. * **Quality Control Unit deficiencies:** Responsibilities and procedures for the quality control unit are not in writing and fully followed. The deviation handling SOP is silent on the content of trend evaluations. * **Equipment design and maintenance:** Equipment lacks appropriate design for intended use, cleaning, and maintenance. Routine calibration of automatic/mechanical equipment is not performed according to a written program. * **Process control and validation:** Critical process parameters for APIs/intermediates are not continuously monitored. Validation batch records for API Process Performance Qualification lack measurable values for raw material loading, with no documentation of quantity. * **Engineering practices:** Concerns exist regarding current engineering practices, despite training. The SOP for drawing/layout approval is silent