# FDA 483 - SWORD HEALTH S.A. - September 07, 2023

Source: https://www.globalkeysolutions.net/records/483/sword-health-sa/a75775db-888c-4209-8cce-143958f18c11

> FDA 483 for SWORD HEALTH S.A. on September 07, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SWORD HEALTH S.A.
- Inspection Date: 2023-09-07
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of SWORD HEALTH S.A., a medical device manufacturer in Porto, Portugal, identified three significant observations. The firm failed to adequately document corrective and preventive action activities, lacked established procedures for design review documentation, and had not established procedures for routine equipment inspection and maintenance. These issues indicate deficiencies in the firm's quality system.

## Related Officers

- [Melanie W. Pishnery](https://www.globalkeysolutions.net/people/melanie-w-pishnery/ff4846b0-ffe1-4df0-9116-4bb238866b3a)

Company: https://www.globalkeysolutions.net/companies/sword-health-sa/0badf792-d561-4bc2-a2a9-2253fc88ca89

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