FDA WARNING_LETTER - Konrad Rejdak, M.D., Ph.D. - May 19, 2023

This FDA Warning Letter, dated May 29, 2024, was issued to Dr. Rejdak of Kliniczny Nr 4 in Lublin, Poland, following an inspection from May 15-19, 2023. The inspection reviewed the conduct of Protocol 161403, "A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)."

The FDA identified violations of 21 CFR Part 312, including: 1. **Failure to prepare and maintain adequate and accurate case histories [21 CFR 312.62(b)]**: Subject ability assessment scores (e.g., INCAT) were not entered into tablets at the time of assessment, with gaps ranging from seven minutes to 25 days. There was no source documentation for 144 assessment values for four subjects over nine visits. Times and/or dates were later edited to appear as if recorded at the time of assessment. The provided response citing poor internet due to COVID-19 was deemed inadequate as affected