FDA releases records that show problems at ByHeart date back years

The FDA has released documents showing that unsanitary conditions at the ByHeart infant formula plant and positive pathogen tests have persisted since at least 2022.

The company is currently under investigation due to an outbreak of infant botulism linked to its powdered infant formula.

As of November 26, there have been 37 confirmed cases of infant botulism among infants fed ByHeart formula. All the kids were hospitalized. In addition, more than 70 cases are awaiting tests to determine whether they were infected with the strain of botulism found in the ByHeart formula.

The company says it has detected botulism in unopened containers of its formula and is recalling all of its products. The Food and Drug Administration found that stores continue to sell the recalled products. The agency urges parents and guardians not to use the ByHeart formula.

Food Safety News filed a Freedom of Information Act request with the FDA earlier this month for all ByHeart-related records, but had not received any documents as of Nov. 26.

The 2023 and 2024 inspection reports released Nov. 26 by the FDA detailed problems found at ByHeart's manufacturing plant in Allerton, Iowa, including positive tests for Cronobacter, as well as leaking roofs and cracks in equipment.

The FDA also issued a warning letter sent on August 30, 2023, covering the inspection from December 21, 2022 to February 17, 2023. Both inspection reports cover issues found in the 2022 inspection and subsequent inspections.

In its heavily redacted 2025 report on the unannounced inspection in February of this year, the FDA cited a variety of problems, including rodent activity and ByHeart's failure to properly monitor floors.

The FDA held seven discussions with ByHeart management regarding significant pest activity, missed inspections by quality control staff, failure to ensure door safety, failure to collect swabs during production for pathogen testing, and failure to take steps to prevent water leaks.

FDA investigators found that the company approved and released an ingredient that was not manufactured, packaged, labeled or stored under conditions that prevent adulteration (contamination).

Investigators also found that ByHeart failed to eliminate pests from its food plant and did not maintain its building in a manner that ensured that baby food was produced and packaged in a clean and sanitary environment. The inspection report also said the ByHeart plant was not designed to facilitate maintenance and sanitation operations.

In the investigative report, the FDA inspector noted that a ByHeart representative at the company's headquarters said the company had received nearly 2,000 complaints related to products made with the base powder. Complaints fall into three categories: Health; Quality; Sensitive/Serious.

Health is related to gastrointestinal diseases. Quality relates to taste, smell, appearance, damage and foreign materials. Sensitive refers to salmonella/pathogenic diseases. The firm said there were reportedly 1,915 quality complaints, 930 health-related complaints and 9 sensitive complaints.

The FDA inspection report noted that ByHeart made several improvements at its Allerton, Iowa, plant, including ceiling repairs, floor sealing and exhaust equipment repairs.

A ByHeart spokesperson told FDA investigators that there have been no process or equipment changes at the baby food line since 2022. The 2023 and 2024 inspection reports document ongoing problems starting in 2022.

ByHeart uses a third party company to perform equipment inspections. The last inspection took place on October 31, 2024.

The company reports swabbing for Cronobacter, Salmonella and other pathogens, but not botulism. He discovered Cronobacter at his enterprise.

An FDA inspector observed employees handling ingredients in a manner that allowed contamination.

According to the January 2024 audit report, the firm and corporate management were given a verbal warning emphasizing the need to comply with the Food, Drug and Cosmetic Act. During this interaction, the consequences of non-compliance with the law were clearly explained to emphasize the importance of compliance with the Law.

“I (the inspector) reviewed the firm's complaint file from June 2023 to the present. There were many complaints about product quality, some specifically citing issues such as spitting up and diarrhea. Complaints related to these health issues are being investigated by company headquarters. The infants involved in these complaints were 71 days old and 90 days old. There were no reports of serious injuries or illnesses. In addition, there were complaints related with color and taste,” says the 2024 inspection report.

An inspection in January 2023 found dozens of cracks in equipment, floors and the roof. Such cracks may harbor foodborne pathogens, including Clostridium botulinum, which causes botulism poisoning.

The 2024 inspection report detailed issues including:

• Records do not provide specific information regarding cleaning, disinfection, and cumulative production of each formula processed between equipment startup and maintenance shutdowns;
• The company's electronic system was created in 2009 and has not been tested since then;
• Gaps in some records and lack of documented records;
• Cronobacter was found in production and storage areas;
• The firm did not provide the FDA with a copy of the audit.

“I (the Inspector) issued a verbal warning to all persons present, emphasizing the importance of compliance with the FD&C Act and emphasizing the consequences of non-compliance.”

The 2023 inspection was purely registration in nature and did not involve sampling of the plant or products. It was heavily edited and many paragraphs were crossed out. The review was conducted on June 27 and 28, 2023 and published on November 26 this year. The previous review was conducted by the FDA on May 15, 2022. She found many problems.

Many of the issues mentioned in the 2023 report were repeated in the 2024 report.

The following observations were documented in the 2023 report and addressed issues that arose from the 2022 inspection. These observations included:

• Lack of written procedures for sanitary preventive control, monitoring, corrective action and inspection to significantly minimize or prevent hazards requiring preventive control;
• Failure of the person who reviewed infant formula quality control procedures to be directly responsible for the matters that that person reviewed;
• The measuring devices used to check the accuracy of the weights of the ingredients in the infant formula base were not calibrated;
• Failure to maintain a building used in the production, processing, packaging or storage of baby food in a clean and sanitary condition.

“The current audit focused on the firm's corrective actions compared to the previous audit. The firm's food safety plan and hazard analysis were reviewed; the plan was not updated to reflect the current owner. Local firm management stated that the firm's processes and procedures are currently being reviewed by ByHeart corporate management and will be updated before Blendhouse Allerton begins producing PIF (powdered infant formula,” the audit report for 2023

“All persons present (during the inspection) were given a verbal warning about the need to comply with the FDC Law and the consequences of non-compliance.

“I have communicated to all parties that continued improvement and regular maintenance of this aging facility will be vital to preventing contamination of the powdered infant formula supply. Hillary Seibert, Senior Vice President of Quality, reiterated the company's (b)(4) commitment to producing quality food products. She stated that the facility is now beginning testing with the intention of sending the product to market this year.”

The August 2023 warning letter, which was partially redacted, included references to activity that began in September 2022. During the inspection that resulted in the Warning Letter, FDA investigators found serious violations of 21 Code of Federal Regulations Part 106 (21 CFR Part 106), “Requirements for Infant Formulas Related to Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Records and Reports, and Notices” (the Infant Formula Rule).

The warning letter cited bacteria, a leaking roof and unsanitary conditions at the manufacturing plant.

“On October 17, 2022, you (ByHeart) notified (edited) that a batch of ByHeart Whole Nutrition Infant Formula finished product tested positive for Cronobacter spp. and was later confirmed as Cronobacter sakazakii (“C. sakazakii”). The baby food base that was a component of the contaminated finished product was manufactured in a continuous production campaign at (edited) at the facility from July 13, 2022 to August 23, 2022. The infant formula base obtained through this campaign was then blended and packaged as a finished product at one of your third party contract manufacturer's facilities from September 15, 2022 to October 7, 2022,” the warning letter states.

The letter noted that ByHeart initially said the positive test was due to a laboratory error, but that was later retracted.

The FDA's review of ByHeart's records found that the company did not work with its third-party contract manufacturer to further investigate the origin or root cause of the finished product testing positive for the pathogen. Because all product marketing decisions are made by the parent company and organization, the FDA has advised ByHeart that it is their responsibility to investigate all aspects of your product's manufacturing process, including the operations conducted at your facility. (edited) and a third-party contract manufacturer's facility when assessing the potential root cause of a product contamination incident.

In response to the positive Cronobacter test, ByHeart initially contained and destroyed only one shipment of baby food. ByHart oversaw the release of all other formulas. Following discussions with the FDA, ByHeart has conducted a voluntary recall of the remaining five batches of formulas from the same campaign, from September 15, 2022 to October 7, 2022, that it previously released into commerce in the United States.