# FDA 483 - Grifols Biologicals LLC - Unknown Date

Source: https://www.keypedia.com/records/483/grifols-biologicals-llc/0ba058fa-58bc-46d9-a53e-be91bdd8cc54

> FDA 483 for Grifols Biologicals LLC on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grifols Biologicals LLC
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Grifols Biologicals, LLC in City of Industry, CA, a plasma fractionation facility, revealed six observations. Deficiencies included inadequate segregation of products and rejected materials, insufficient temperature control in a staging warehouse, and poor documentation practices for inspections, warehousing procedures, and batch records. These issues indicate a lack of control over product integrity and manufacturing processes.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/grifols-biologicals-llc/7779b39c-a161-470f-ab0f-ff0c2c715022)

## Related Officers

- [Olga Simakova](https://www.keypedia.com/people/olga-simakova/2ee5985e-425e-4732-8869-2be861f5d792)
- [issuing_officer](https://www.keypedia.com/people/omotunde-osunsanmi/41c6ef66-1d5c-4940-8b1f-628da20cde34)
- [Decarlos A. Gomez](https://www.keypedia.com/people/decarlos-a-gomez/4b003235-edbb-4cb5-acb1-4e154941578c)
- [issuing_officer](https://www.keypedia.com/people/malgorzata-g-norton/ba7b8827-0976-4abd-8abb-95d4222d2bdc)
- [Nobuko Katagiri](https://www.keypedia.com/people/nobuko-katagiri/dbffc4f1-46a9-4149-bba1-842d67086d68)

Company: https://www.keypedia.com/companies/grifols-biologicals-llc/206a08df-1e93-4280-b926-83661b2bb985

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6