The FDA warned ByHeart about insanitary conditions in their facility more than two years ago during the worry about Cronobacter in infant formula. A warning letter was sent on August 30, 2023. The letter states, “During our inspection at the (b)(4) facility, FDA investigators found significant violations of Title 21, Code of Federal Regulations, Part 106 (21 C.F.R. Part 106), Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications (“the Infant Formula Rule”).”
This information is interesting because powdered ByHeart Whole Nutrition Infant Formula is linked to a botulism outbreak that has sickened 15 infants in 12 states. The California Department of Health conducted testing on an open can of that formula and found presumptive evidence that Clostridium botulinum was in the product.
A form FDA-483 was issued at the end of the 2023 inspection, listing the deviations at the plant. The inspection was conducted on December 21, 2022. The company sent corrective action responses on March 10, 2023, April 10, 2023, April 27, 2023, May 10, 2023, June 9, 2023, and July 17, 2023. The agency still had concerns.
They found that the company didn’t establish a system of process controls covering all stages of processing, designed to make sure that the formula did not become adulterated. There was a batch of the finished product that tested positive for Cronobacter. A root cause analysis was conducted, saying that the post-production sample handling by a third party lab was the source of the contamination, resulting in a laboratory error. But the lab error was not found or supported. A lab error is supposed to be supported with confirmed evidence, but there was no evidence to the contrary.
ByHeart did not make any more effort to evaluate other routes of contamination that may have contributed to this issue. They did not work with the third-party contract manufacturer to investigate the root cause of the positive findings. The FDA states that it is ByHeart’s responsibility, as the parent company, to investigate all aspects of production when evaluating root causes for a product contamination.
In addition, there were two events when water from outside the building leaked into the manufacturing areas. A leak through the skylight occurred in the processing room. Cronobacter was found in that processing room, but the root cause analysis never evaluated whether the leak contributed to the contamination.
Then there was a leak in the sealant around the louver on a Dryer Tower. Four swabs detected Cronobacter in different locations of the tower, but the root cause analysis, again, never evaluated whether the leak in the least may have contributed to the contamination.
Finally, on October 15, 2022, ByHeart notified its third-party contract manufacturer that ByHeart Whole Nutrition Infant Formula tested positive for Cronobacter. The company directed the manufacturer to destroy certain lots. The lot that tested positive and the first pallet were destroyed, but other lots manufactured as part of the same campaign were released. The FDA found that the firm released adulterated powdered infant formula into U.S. commerce. A voluntary recall was issued in December 2022. That recall was effective, according to the FDA.
These problems in the plant may not have anything to do with the potential botulism contamination, but they are indicative of issues with process controls.
