FDA EIR - Prolacta Bioscience Inc - March 25, 2014

An FDA inspection of Prolacta Bioscience, Inc., a manufacturer of human milk-based infant formula products targeting premature infants, was conducted from March 25 to May 1, 2014. This initial, comprehensive inspection aligned with the Infant Formula Program, Domestic Food Safety Program, NLEA and General Food Labeling Requirements, and Good Manufacturing Practices. The inspection scope included manufacturing operations, raw material receiving, production and quality records, equipment calibration, and compliant files. Specialists also reviewed the firm's pasteurization system, equipment designs, and conducted a biologics evaluation covering donor qualification, records, and raw materials. While no formal FDA Form 483 (Inspectional Observations) was issued, 24 items related to pasteurization, equipment design, and biologics evaluation were discussed with firm management. Prolacta Bioscience committed to providing a written response to these discussion points. The inspection concluded with a 'No Action Indicated' classification, indicating no significant regulatory violations were found. No consumer complaints or recalls were noted for the firm.