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

Source: https://www.globalkeysolutions.net/records/483/sirona-hygiene-private-limited/6b03667a-c034-4101-9cdc-9f23493e19d1

> FDA 483 for Sirona Hygiene Private Limited on May 25, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sirona Hygiene Private Limited
- Inspection Date: 2023-05-25
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.globalkeysolutions.net/companies/sirona-hygiene-private-limited/d9dd96bf-8c71-497a-9626-8c3be331206b

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd