FDA 483 - Grifols Therapeutics LLC - February 05, 2026
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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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