FDA 483 - Marc C. Gittelman, M.D. - August 26, 2021

An FDA inspection of Marc C. Gittelman, M.D., Clinical Investigator in Aventura, FL, from August 17-26, 2021, revealed a significant issue with data integrity. The firm failed to maintain accurate case histories, specifically lacking documentation for critical laboratory sample processing procedures for blood collection tubes. This indicates a serious lapse in record-keeping for clinical investigations.