# FDA 483 - Laboratorio Reig Jofre S.A. - June 14, 2019

Source: https://www.globalkeysolutions.net/records/483/laboratorio-reig-jofre-sa/6a7449f7-e208-4161-b001-4e6abbeb7236

> FDA 483 for Laboratorio Reig Jofre S.A. on June 14, 2019. 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: 2019-06-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Laboratorio Reig Jofre S.A., a sterile drug manufacturer in Toledo, Spain, revealed significant deficiencies across its production, quality control, and laboratory systems. Observations included inadequate procedures to prevent microbial contamination, failures in quality unit responsibilities and CAPA management, and insufficient laboratory controls for product release. These issues indicate a lack of robust controls essential for ensuring the quality and sterility of drug products.

## Related Documents

- [483 - 2023-06-23](https://www.globalkeysolutions.net/records/483/laboratorio-reig-jofre-sa/0e436382-a265-4af7-bd75-d77eed6d5f27)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)

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