# FDA 483 - FAMAR HEALTH CARE SERVICES MADRID SA - April 26, 2024

Source: https://www.keypedia.com/records/483/famar-health-care-services-madrid-sa/18644483-123c-4f5a-b2d4-ed8fa79c0c83

> FDA 483 for FAMAR HEALTH CARE SERVICES MADRID SA on April 26, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FAMAR HEALTH CARE SERVICES MADRID SA
- Inspection Date: 2024-04-26
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Famar Health Care Services Madrid S.A. in Alcorcon, Madrid, Spain, revealed significant deficiencies in sterile drug product manufacturing procedures and environmental monitoring. The firm also lacked proper written specifications for laboratory controls, indicating a need for comprehensive corrective actions to ensure product quality and safety.

## Related Officers

- [Lori B. Wikstrom](https://www.keypedia.com/people/lori-b-wikstrom/19d938f7-4a5d-42b9-b2d1-e92cdb63bb0d)

Company: https://www.keypedia.com/companies/famar-health-care-services-madrid-sa/714d760c-6b6d-4a4b-9b1e-998380c3ba18

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3