# FDA 483 - Grifols Therapeutics LLC - February 05, 2026

Source: https://www.keypedia.com/records/483/grifols-therapeutics-llc/f00000c6-d7fa-4773-9efc-0d7051024010

> FDA 483 for Grifols Therapeutics LLC on February 05, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grifols Therapeutics LLC
- Inspection Date: 2026-02-05
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: Grifols Therapeutics LLC in Clayton, NC, a plasma derivatives facility, was cited for significant quality control issues during an FDA inspection. Observations included a failure to thoroughly investigate recurring discrepancies like IGM excursions and missing sample results, as well as a failure to report serious adverse events within the required 15-day timeframe. Additionally, the firm did not adhere to its own written production and process control procedures for product rework.

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## Related Officers

- [Jennifer L. Reed](https://www.keypedia.com/people/jennifer-l-reed/56fd0817-0bda-4148-8d3a-61093961390d)
- [Katarzyna I. Jankowska](https://www.keypedia.com/people/katarzyna-i-jankowska/b3751945-6b2f-4990-810b-6d6a86949568)
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- [Vijaya L. Simhadri](https://www.keypedia.com/people/vijaya-l-simhadri/dfae7da4-91e0-4cb4-8b23-afcb351a6e44)

Company: https://www.keypedia.com/companies/grifols-therapeutics-llc/2e4dd489-4e70-4ef7-a1f8-f0267f91fab5

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7