FDA 483 - Grifols Therapeutics LLC - February 05, 2026

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.