# FDA 483 - Laboratorios Farmalan, S.A. - March 19, 2019

Source: https://www.globalkeysolutions.net/records/483/laboratorios-farmalan-sa/75e127e8-8f4e-442c-aaff-5ccbc255dab2

> FDA 483 for Laboratorios Farmalan, S.A. on March 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laboratorios Farmalan, S.A.
- Inspection Date: 2019-03-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Laboratorios Farmalan, S.A. in Leon, Spain, a sterile drug manufacturer, received a Form FDA 483 with five observations. The inspection revealed significant deficiencies in investigation procedures for discrepancies and OOS results, inadequate laboratory controls, and poor environmental monitoring in aseptic processing areas. Additionally, issues were noted with equipment control for microorganisms and humidity, and a lack of established control procedures for manufacturing process validation.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.globalkeysolutions.net/companies/laboratorios-farmalan-sa/d181ee79-2a09-49d7-bd66-9a5275577957

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