# FDA 483 - Laboratorios Grifols, S.A. - July 26, 2024

Source: https://www.keypedia.com/records/483/laboratorios-grifols-sa/dc35537c-0468-4727-8f76-05c40b387f41

> FDA 483 for Laboratorios Grifols, S.A. on July 26, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laboratorios Grifols, S.A.
- Inspection Date: 2024-07-26
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Laboratorios Grifols, S.A. in Parets Del Valles, Spain, a drug manufacturing facility, was cited for four observations during an FDA inspection from July 22-26, 2024. The observations primarily concern deficiencies in written procedures for production and process controls, incomplete batch and laboratory records, and inadequate cleaning and maintenance procedures. These issues indicate a lack of robust control over critical manufacturing and testing processes.

## Related Officers

- [Investigator](https://www.keypedia.com/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.keypedia.com/companies/laboratorios-grifols-sa/85023467-ba39-4c58-bbd9-43175c876342

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321