# FDA 483 - Grifols Biologicals LLC - Unknown Date

Source: https://www.keypedia.com/records/483/grifols-biologicals-llc/7779b39c-a161-470f-ab0f-ff0c2c715022

> 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: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Grifols Biologicals Inc. in City of Industry, CA, a biologic drug manufacturer, revealed significant deficiencies in facility maintenance and quality systems. Observations included a building not maintained in a good state of repair with water damage and structural issues, and a lack of formal agreements and procedures for facility upkeep with a sister corporation. These issues indicate a failure to ensure proper control over the manufacturing environment and related processes.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/grifols-biologicals-llc/0ba058fa-58bc-46d9-a53e-be91bdd8cc54)

## Related Officers

- [Gene D. Arcy](https://www.keypedia.com/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)

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

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