FDA EIR - Prolacta Bioscience Inc - November 22, 2019

An FDA inspection of Prolacta Bioscience Inc., a manufacturer of donor human milk and human milk-based infant formula, was conducted from November 15-22, 2019, in City of Industry, CA. This comprehensive inspection, initiated due to a referral concerning Bacillus cereus findings in donor breastmilk, focused on good manufacturing practices for products like Prolact +4 Human Milk Fortifier. The regulatory framework for the inspection covered FDA's Infant Formula Program (7321.006), Preventive Controls and Sanitary Human Food Operations (7303.040), and Nutritional Labeling and Education Act (7321.005), emphasizing adherence to infant formula regulations (21 CFR Part 106).

While no formal FDA-483 observations were issued, several significant issues were discussed with management. These included an inadequate volume of test samples for bioburden, long ramp-up and ramp-down times in pasteurization allowing potential bacterial growth, and manual manipulation during mineral addition as a contamination risk. Concerns were raised about the statistical validity of microbial analysis, poor sanitation in non-production areas (loading dock, warehouse, freezers) lacking dedicated procedures and records, and an over-reliance on certain process controls. The absence of indicating thermometers for product temperatures and the need for more frequent chemical testing of water samples were also noted.

Required actions, presented as recommendations, included documenting actual conductivity test results, establishing clear sanitation procedures for non-production spaces, diversifying environmental monitoring sampling locations with intensified cleaning post-positive findings, implementing indicating thermometers with manual temperature logging, regular meter challenges, and developing a robust freezer sanitation program to control pathogen risks.