We are deeply appreciative of the FDA’s comprehensive investigation over the past several months. FDA's update today verifies that inspection into ByHeart’s facilities are complete and that the FDA has declared an end to the outbreak. FDA has shared that it did not identify any deficiencies in ByHeart’s facilities that could explain the root cause of this outbreak.

FDA continues its investigation into the powdered milk ingredient produced by a third party supplier where Clostridium botulinum was identified.

The FDA is now working with ByHeart on the safe resumption of infant formula production. Nothing is more important than the safety of the babies we nourish. As part of a comprehensive Action Plan, we have worked with a reputable third-party lab partner to develop a new Clostridium botulinum specific testing protocol with heightened sensitivity to previously used protocols that will be applied to every dairy ingredient and to finished batches before they are released from our facilities.

We plan to share our commitments and plans for action that reflect how seriously we take our responsibility in the near future.