FDA 483 - Olgam Life LLC - October 29, 2025

Olgam Life LLC, a source plasma establishment in Bronx, NY, was cited for three observations during an FDA inspection. The firm failed to consistently follow written standard operating procedures for blood collection, did not maintain accurate quality control and general records, and lacked regular observation and standardization of equipment used in blood component collection. These issues indicate deficiencies in procedural adherence, record integrity, and equipment management.