# FDA 483 - Laboratorio Reig Jofre S.A. - June 23, 2023

Source: https://www.globalkeysolutions.net/records/483/laboratorio-reig-jofre-sa/0e436382-a265-4af7-bd75-d77eed6d5f27

> FDA 483 for Laboratorio Reig Jofre S.A. on June 23, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laboratorio Reig Jofre S.A.
- Inspection Date: 2023-06-23
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Laboratorio Reig Jofre S.A. in Toledo, Spain, a sterile drug product manufacturer, was cited for significant deficiencies across its quality control, complaint investigation, and sterile manufacturing processes. Observations included inadequate visible particle testing, deficient complaint investigations for particulate matter, and a lack of established procedures to prevent microbiological contamination. The firm also failed to maintain complete laboratory records, ensure accurate test methods, and provide adequate employee training.

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## Related Officers

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Company: https://www.globalkeysolutions.net/companies/laboratorio-reig-jofre-sa/a6b83a70-2bd5-4cc1-8007-61357916a14f

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1