FDA WARNING_LETTER - ByHeart, Inc. - February 17, 2023

The FDA issued a Warning Letter to ByHeart, Inc. (parent company of (b)(4)) following an inspection of their powdered infant formula facility in (b)(4), PA, from December 21, 2022, to February 17, 2023. The inspection revealed significant violations of 21 C.F.R. Part 106, the Infant Formula Rule, specifically regarding process controls to prevent microbial adulteration.

Key violations include: 1. **Failure to establish adequate process controls (21 C.F.R. § 106.55(a)):** * **Inadequate Root Cause Analysis (RCA) for *Cronobacter sakazakii* (C. sakazakii) contamination:** A finished product batch tested positive for C. sakazakii. ByHeart's RCA attributed this to third-party lab error, despite the lab's report refuting this. ByHeart failed to investigate other contamination routes, including operations at their third-party contract manufacturer. * **Insufficient investigation of C. sakazakii in infant formula base:** An infant formula base tested positive for C. sakazakii due to an intervention into a product contact zone without proper procedures. While the lot was destroyed, the RCA did not adequately evaluate intervening sanitation breaks or conduct Whole Genome Sequencing (WGS) on the isolate to compare with