# FDA 483 - Grifols Biologicals LLC - May 03, 2024

Source: https://www.globalkeysolutions.net/records/483/grifols-biologicals-llc/7b1f6f5b-1e20-4269-900f-2747e5a5b017

> FDA 483 for Grifols Biologicals LLC on May 03, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grifols Biologicals LLC
- Inspection Date: 2024-05-03
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Grifols Biologicals LLC in Los Angeles, CA, a biologics and plasma derivatives facility, revealed significant deficiencies across multiple areas. Observations included inadequate environmental monitoring in aseptic processing areas, failure to follow complaint handling procedures for drug products, and poor maintenance of manufacturing buildings. These issues indicate a lack of control over critical manufacturing processes and quality systems.

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- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/grifols-biologicals-llc/809e049f-363a-4eed-9609-495aa42b600d)

## Related Officers

- [Peng Zhou](https://www.globalkeysolutions.net/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)
- [Investigator](https://www.globalkeysolutions.net/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)
- [Gene D. Arcy](https://www.globalkeysolutions.net/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)

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

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