Prolacta Bioscience, Inc – FDA EIR, Jul 29, 2021

An FDA routine surveillance inspection of Prolacta Bioscience's Duarte, CA facility occurred on July 29, 2021. This was the initial FDA inspection of the donor human milk warehouse and receiving facility. The inspection was conducted under Compliance Programs for Infant Formula and Preventive Controls and Sanitary Human Food Operations, covering good manufacturing practices and infant formula regulations. The review encompassed batch records, equipment calibration, sanitation, environmental monitoring programs, and raw milk receiving processes. Notably, the FDA did not issue any formal inspectional observations (FDA-483) at the conclusion of the inspection, indicating a generally compliant operation. However, discussions with management highlighted areas for internal review and improvement. These included the need for a study to determine appropriate cooling times for 2.5L containers stored in the freezer, particularly considering worst-case scenarios for effective cooling. Additionally, the FDA advised Prolacta Bioscience to ensure their food facility registrations accurately reflect all activities conducted at each location. The firm also acknowledged an internal lapse in providing annual Good Manufacturing Practices (GMP) training in 2020 due to the COVID-19 pandemic and committed to implementing a new training module by August 2021. The inspection did not involve sample collection or encounter any refusals.