# FDA 483 - Grifols Biologicals LLC - Unknown Date

Source: https://www.keypedia.com/records/483/grifols-biologicals-llc/809e049f-363a-4eed-9609-495aa42b600d

> 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: Grifols Biologicals, LLC in Los Angeles, CA, was cited for significant manufacturing and quality control deficiencies during an FDA inspection. The firm experienced multiple recalls of its IGIV-C product due to serious allergic reactions, failed to conduct thorough investigations into these issues, and exhibited inadequate procedures for adverse event evaluation, complaint handling, and microbiological contamination prevention. The observations highlight a systemic breakdown in quality systems, including training and laboratory controls, posing a risk to product quality and patient safety.

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## Related Officers

- [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)
- [Nobuko Katagiri, Ph.D., Research Biologist](https://www.keypedia.com/people/nobuko-katagiri-phd-research-biologist/66227861-580f-47ad-8f9d-1228469e538b)
- [Olga Simakova, Ph.D., Biologist](https://www.keypedia.com/people/olga-simakova-phd-biologist/89ab2639-00a3-4dc1-9f97-5d17a43e9a66)
- [Vijaya Simhadri, Ph.D., Staff Fellow](https://www.keypedia.com/people/vijaya-simhadri-phd-staff-fellow/b7ab3ada-dfcf-4ec3-8d43-d1a7504f203b)

Company: https://www.keypedia.com/companies/grifols-biologicals-llc/817fe827-22a0-42d2-8bb4-2c1e77a30038

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