# FDA 483 - Hospira Zagreb d.o.o. - Unknown Date

Source: https://www.keypedia.com/records/483/hospira-zagreb-doo/9f881383-a493-4fc4-9875-f966fa11b15f

> FDA 483 for Hospira Zagreb d.o.o. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hospira Zagreb d.o.o.
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: An FDA inspection of Hospira Zagreb d.o.o. in Prigorje Brdovečko, Croatia, revealed significant issues in their drug substance and drug product manufacturing facility. The firm experienced a critical malfunction during sterile drug product manufacturing, resulting in contamination and batch rejection. Additionally, written procedures for manufacturing and testing were found to be inadequate, particularly concerning outlier elimination in bioassays and the determination of equivalent chromatography columns.

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Company: https://www.keypedia.com/companies/hospira-zagreb-doo/7c1e84f8-a21e-4e90-896a-ac33304219f1

Office: https://www.keypedia.com/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0