# FDA 483 - Laboratorios Liconsa SAU - January 17, 2025

Source: https://www.globalkeysolutions.net/records/483/laboratorios-liconsa-sau/22c213fc-8195-450c-b6af-58d7205a9386

> FDA 483 for Laboratorios Liconsa SAU on January 17, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Laboratorios Liconsa SAU
- Inspection Date: 2025-01-17
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Laboratorios Liconsa, a bioanalytical facility in Azuqueca de Henares, Spain, revealed significant deficiencies in method validation and documentation practices. The observations primarily concern inadequate stability determinations for stock solutions, incomplete reporting of analytical sequences, and insufficient documentation to reconstruct method validation experiments. These issues indicate a lack of robust quality control in their analytical processes.

## Related Documents

- [483 - 2025-01-17](https://www.globalkeysolutions.net/records/483/laboratorios-liconsa-sau/4de04511-c656-441f-b0e6-ccf88827097b)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/ruben-c-ayala/6b5dadad-56b8-4af0-a65f-4685f71f0c8d)

Company: https://www.globalkeysolutions.net/companies/laboratorios-liconsa-sau/ab88a2bb-8c52-445d-8417-82ea8f48bdf6

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