FDA 483 - Lupin Limited - November 21, 2025

During an FDA inspection conducted from August 21 to September 8, 2023, medical device manufacturer Medtronic Inc. received a Form 483 outlining significant deficiencies in its quality system. The observations centered on several critical areas, many of which were repeat findings from previous inspections. Key issues included a lack of adequately established procedures for corrective and preventive actions (CAPA), specifically concerning the verification of effectiveness for implemented changes and the analysis of quality data to identify nonconforming products. The firm also failed to consistently follow its complaint handling procedures, neglecting to document product analysis results. Furthermore, the inspection revealed deficiencies in incoming product acceptance activities and a lack of employee awareness regarding potential defects from improper job performance. Critical processes, such as a device manufacturing process and device design validation, were found to be unvalidated or inadequately established, with observed failures not being properly documented or investigated. Additionally, device history records were incomplete, and the company failed to fully implement its Medical Device Reporting (MDR) procedures, leading to delays in completing investigations for adverse events. A recall notification was also not submitted to the FDA within the required timeframe. These observations indicate that Medtronic Inc. needs to undertake comprehensive corrective actions to enhance its quality management system, ensuring compliance with medical device regulations and preventing recurrence of identified issues.