483
Sirona Hygiene Private LimitedSirona Hygiene Private Limited – FDA 483, May 25, 2023
Record Details
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.
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ID · 6b03667a-c034-4101-9cdc-9f23493e19d1
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