Long Island Jewish Medical Center – FDA 483, May 1, 2026

An FDA inspection of Long Island Jewish Medical Center's Blood Bank revealed significant deficiencies in its operations. The facility failed to consistently establish, maintain, and follow standard operating procedures for the storage, distribution, and visual inspection of blood products, as well as for handling mislabeled specimens. Additionally, the inspection found a failure to maintain adequate processing, quality control, and general records, including those related to investigations, blood reconstitution, and specific processing cycles.