FDA 483 - Sirona Hygiene Private Limited - May 25, 2023

During an inspection by the U.S. Food and Drug Administration (FDA) from May 22 to May 25, 2023, Sirona Hygiene Private Limited, a manufacturer in New Delhi, India, received a Form FDA 483 outlining four significant observations concerning its quality management system. The main issues identified included the absence of established written procedures for corrective and preventive actions, which are fundamental for addressing and preventing quality deficiencies. Additionally, the company's procedures for design changes were deemed inadequate, failing to ensure proper definition and documentation of modifications, their reasons, evaluation, and impact on product quality. Crucially, the firm lacked comprehensive procedures for effectively receiving, reviewing, and evaluating customer complaints. This deficiency meant the complaint handling process did not ensure uniform and timely processing, proper documentation of oral complaints, or a systematic evaluation to determine the necessity of an investigation or potential Medical Device Reporting (MDR) requirements. Lastly, Sirona Hygiene Private Limited had not developed, maintained, or implemented written procedures for Medical Device Reporting itself. These observations collectively indicate a need for the company to enhance its operational controls and quality system to align with regulatory standards. The company confirmed its commitment to rectify each identified observation.