Natren, Inc. – FDA 483, Oct 8, 2019

Natren, Inc., a manufacturer of probiotic and other products in Thousand Oaks, CA, was inspected by the FDA. The inspection revealed significant issues with laboratory control documentation, including a lack of real-time record-keeping and unreviewed data transfers. Additionally, the firm failed to investigate and justify temperature excursions in its packaging room, leading to potential quality concerns for its products.