483
Kessler Foundation IRBFDA 483 - Kessler Foundation IRB - January 15, 2026
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An FDA inspection of Kessler Foundation IRB in West Orange, NJ, revealed a significant deficiency in their institutional review board procedures. The firm lacks a written procedure for conducting initial research reviews, specifically regarding the calculation of IRB approval dates for studies approved pending modifications. This issue led to a gap in approval for one protocol, indicating a lapse in oversight.
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