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

Source: https://www.globalkeysolutions.net/records/483/laboratorios-liconsa-sau/4de04511-c656-441f-b0e6-ccf88827097b

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

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## Details

- Record Type: 483
- Company Name: Laboratorios Liconsa SAU
- Inspection Date: 2025-01-17
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Laboratorios Liconsa's bioanalytical facility in Azuqueca de Henares, Guadalajara, Spain, identified significant deficiencies in method validation and documentation practices. The firm failed to adequately determine the stability of stock solutions, include all tested analytical sequences in reports, and maintain complete documentation for method validation experiments. These issues indicate a lack of robust quality control and record-keeping for critical analytical processes.

## Related Documents

- [483 - 2025-01-17](https://www.globalkeysolutions.net/records/483/laboratorios-liconsa-sau/22c213fc-8195-450c-b6af-58d7205a9386)

## 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/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8