FDA EIR - Prolacta Bioscience Inc - July 30, 2021

Prolacta Bioscience Inc. underwent a routine FDA surveillance inspection at its City of Industry, CA facility from July 26-30, 2021. The inspection covered good manufacturing practices and Infant Formula regulations, aligning with Compliance Programs for Infant Formula, Preventive Controls, Sanitary Human Food Operations, and Nutritional Labeling. Notably, no formal FDA-483 Inspectional Observations were issued. However, the inspection highlighted several areas for discussion and potential improvement. These included enhancing environmental monitoring for compressed air by increasing data frequency beyond monthly tests, and improving pasteurization batch records to include actual temperature readouts from thermometers, rather than just 'yes/no' confirmations. Further discussions recommended identifying clear operating ranges for parameters like pressure and flow in Ultrafiltration (UF) process records. The FDA also advised routine challenge testing of the labeling machine to ensure it effectively identifies and rejects mislabeled products, along with consistent calibration of critical instruments like mixer sensors. Management was encouraged to re-evaluate the manual mineral addition process due to its high-risk nature involving extensive handling and product exposure, considering changes to mitigate potential contamination. This review also ties into the firm's ongoing evaluation of a S. aureus enterotoxin testing program, with a suggestion to assess if the mineral addition step influences S. aureus viability. The company had previously identified that annual GMP training for 2020 was not completed due to COVID, for which they had already created an internal Observation Report. No samples were collected, and no refusals were encountered during this inspection.