# FDA 483 - Instituto Grifols, S.A. - Unknown Date

Source: https://www.keypedia.com/records/483/instituto-grifols-sa/4939d8ab-7d38-4600-a6f3-933122f8dc31

> FDA 483 for Instituto Grifols, S.A. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Instituto Grifols, S.A.
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Instituto Grifols, S.A., a biologic plasma fractionation and finished drug manufacturer in Parets del Valles, Spain, was cited for two significant observations. The firm's Quality Unit lacked authority to properly investigate recurring power loss issues affecting critical systems and products, failing to link deviations or implement corrective actions. Additionally, investigations into a serious adverse event, including a patient death associated with an immunoglobulin product, were not promptly initiated or completed.

## Related Documents

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Company: https://www.keypedia.com/companies/instituto-grifols-sa/478ef862-9ed8-4172-919f-c7475c316b61

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