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

Sirona Hygiene Private Limited, a medical device manufacturer in New Delhi, India, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacked established written procedures for corrective and preventive actions, design changes, and complaint handling. Additionally, the company failed to develop and implement written Medical Device Reporting (MDR) procedures.