FDA shuts down animal food manufacturer due to Salmonella – Is Abbott infant formula with Cronobacter next?

The U.S. Food and Drug Administration (FDA) announced today that Bravo Packing, Inc., an animal food manufacturing company of Carney’s Point, New Jersey, has agreed to stop selling, manufacturing and distributing raw pet food and come into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Today’s action marks the first consent decree of permanent injunction against an animal food manufacturer for violating public safety standards under Part 507 (Current Good Manufacturing Practice (CGMP) requirements) of the Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food Regulation. Part 507 requires, among other things, that animal food facilities take adequate precautions to prevent animal food from becoming contaminated and that all animal food manufacturing, processing, packing, and holding is conducted under the conditions necessary to minimize the potential for the growth of undesirable microorganisms to protect against the contamination of animal food.

“The food we give our pets should be safe for them to eat and safe for people to handle,” said Steven Solomon, DVM, MPH, director of FDA’s Center for Veterinary Medicine. “The FDA has taken this action to protect public health because, despite multiple inspections, notifications of violations, and recalls, this firm continued to operate under insanitary conditions and produce pet food contaminated with harmful bacteria. We will not tolerate firms that put people or animals at risk and will take enforcement actions when needed.”

The FDA conducted inspections in 2019 and 2021 and issued a warning letter to the facility in 2020. During these inspections, the FDA found evidence of significant food safety violations including grossly insanitary conditions and the failure to follow CGMP regulations for animal food. Multiple samples of finished raw pet food products collected during the inspections tested positive for Salmonella. Pet food that is contaminated with Salmonella can lead to illness in both the pets consuming the food, as well as humans, who handle the food and care for the pets. Some of these finished samples as well as environmental samples from the two inspections also tested positive for Listeria monocytogenes.

The consent decree of permanent injunction entered by U.S. District Judge Noel L. Hillman between the FDA and Bravo Packing, Inc., along with the company’s owner and secretary, Joseph Merola, and its president, Amanda Lloyd, prohibits the defendants from receiving, preparing, processing, packing, holding, labeling, and/or distributing pet food unless and until the company completes corrective actions. The decree also allows the FDA to order a shutdown, recall, or other corrective action in the event of future violations and requires the defendants to pay the costs of inspections performed pursuant to the decree. Failure to abide by the agreement can also lead to civil or criminal penalties.

On February 10, 2022, CDC was notified of the Food and Drug Administration’s (FDA’s) investigation of consumer complaints of infant illness related to products from Abbott Nutrition in Sturgis, Michigan.

The most recent investigation details are summarized below:

From September 16, 2021, to January 5, 2022, CDC received reports of three Cronobacter cases in infants that were later found to be included in FDA’s ongoing investigation. On February 16, 2022, CDC asked clinicians and state and local health departments to provide information on other Cronobacter infections associated with infant formula from November 2020 through the present. Since then, CDC has identified one additional case of Cronobacter infection in an infant who consumed formula produced at this facility.

• Four infants with Cronobacter infections in Minnesota (1), Ohio (2), and Texas (1) consumed formula produced at the Sturgis, Michigan, facility before they got sick.
• Formula types included Similac Sensitive, Similac Pro-total Comfort, Similac Advance, and Similac PM 60/40.
• Cronobacter infections may have contributed to the deaths of two infants in Ohio.

CDC performed whole genome sequencing (WGS) on Cronobacter bacteria isolated from two available patient samples to compare them with environmental samples taken at the facility to determine if there is any relation.

At this time, CDC has completed laboratory testing for the two available patient samples. The analysis performed by WGS did not find these samples from patients to be closely genetically related to the multiple strains of Cronobacterfound in the environmental samples obtained from Abbott Nutrition’s Sturgis, MI facility. Furthermore, WGS showed that bacteria from available patient samples were not closely related to one another. During the course of this investigation, FDA collected additional product samples from the facility and FDA analysis is ongoing.

FDA received one complaint of an infant with a Salmonella infection who consumed infant formula from the Sturgis facility. However, there is not enough information available to definitively link this illness to the recalled infant formula. CDC confirmed that this single Salmonella illness is not linked to an outbreak. CDC is working with state and local partners to monitor for Salmonella illnesses linked to infant formula.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.