Three More Infant Formula Producers Get FDA Warning Letters about Their Spray Drying & Powder Dry Blending Facilities

With the news last Wednesday (August 30, 2023) that the FDA sent Warning Letters to three of the six major Infant Formula Producers in the U.S., the focus on hygienic plant design/procedures and equipment that can be operable under those procedures will be paramount. I expect that this will trickle down to the direct ingredient suppliers of all the Infant Formula producers and that the ripples will continue throughout the food and dairy industry. Moreover, the FDA is responding to the presence of Cronobacter Species on surfaces not in direct contact with product (FDA Zone 2) as being a measure of finished product quality. Product that just tests ok, isn’t ok. It has to test acceptably AND be made in a facility that also tests acceptably since microbiology is a matter of degree. It isn’t that there are or aren’t pathogens. It’s a stats game.

After the severe disruption to the Infant Formula supply chain in 2022 due to another FDA warning, and the subsequent empty store shelves, the seriousness is heightened.

Hygienic plant design and equipment has been fairly good over the years, but there continues to be improvement in the details. For example, the innovation that led to BFM fittings (snap-fit flexible connectors) has led to a better, more clean-able, and more leak-free implementation of flexible connectors. This is just one example of the evolution of the design of spray drying equipment as it relates to hygienic design. CIP procedures, when maintained and implemented properly, have also been effective at keeping equipment sanitary.

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Jim Kent

Jim Kent

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The greatest change in th.e. leading plants in recent years is the adoption of a “Food Safety Culture.” This is not my term, but one adopted by the Innovation Center for US Dairy. In October of 2020, they published the document “Controlling Pathogens in Dairy Processing Environments.” This is the new cornerstone for pathogen control. It easily can be applied beyond dairy.

The overarching concept is that the Principles for Effective Pathogen Control arise from the following when applied together:

  • Clear Separation within the plant of Raw Ingredients or Intermediate production from Final Ready-to-Eat Product
  • Good Manufacturing Practices are applied in an environment of controlled conditions
  • The Facility and Equipment are designed with pathogen control in mind
  • Effective implementation of Sanitation Procedures and Cleaning Procedures; and that effective controls are in place, making sure that the procedures are followed
  • Effective Environmental Pathogen Monitoring

Experts say that contamination issues often aren’t just one thing, but the culmination of multiple missteps that create an avalanche. Food safety is a journey, not a destination. There are always new and emerging pathogens of concern and ever increasing ways to detect them, like Whole Genome Sequencing (WGS). Investigators can now get the DNA of the actual pathogen found in the product. They know not only the species, but precisely the unique genome of the replicating individual bacterium at a plant and can therefore trace it back to the plant from which it came.

I keep a copy of the U.S. Dairy guidelines around for reference and go to it often. 

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About Caloris

Caloris transforms process systems design for the better with unexpected, future-focused solutions that solve real operational problems. We engineer efficient, dependable and productive solutions that also improve environmental sustainability where practical. Designed with the end user in mind to drive plant productivity. Caloris offers evaporation, membrane filtration and spray drying process systems for food and dairy industries, as well as for water reuse and wastewater treatment applications. Both Caloris’ custom and pre-engineered packaged systems are designed to meet our customers’ specific concentration/purification needs utilizing the most cost effective and energy efficient technologies available. Whether concentrating dairy, food or juice products at a high-volume production facility, or processing industrial wastewaters to reduce transportation and treatment costs and recover re-usable water, Caloris provides a range of options and technologies.