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Pepsi Cited For Salmonella Contamination

Food safety plans should be comprehensive

Pepsi Cited For Salmonella Contamination

This is a cautionary tale of how quality control, food safety oversight, and sanitation, even at one of the world's largest companies, can go wrong.

Salmonella was discovered at one of Pepsi's granola bar manufacturing facilities. Here's the timeline.

  • 11/25/23: Sample confirmed to have Salmonella.

  • 12/12/23: Testing reconfirmed Salmonella after a suspected lab error investigation. The sample matched the same form of Salmonella that was previously found in the facility a few months before.

➡ Asa comments: Finding Salmonella in a facility is not uncommon, but not taking the proper steps to remove it from the facility with hazard analysis, cleaning, and testing is a concern.

  • 12/14/23: Company notified FDA of the recall of some lots of granola products. In this warning letter, FDA reminds the company of its obligation to file with the Reportable Food Registry within 24 hours of determining the food should be reported.

➡ Asa comments: Not following FDA's reporting timeline is a good way to irritate the inspector.

  • 12/19/23: FDA sent the "swab patrol," which usually does not happen so quickly after a recall. One of the samples was positive for Salmonella in a crack in the floor.

➡ Asa comments: Floor cracks are common hiding places for these pathogens, which shows the importance of not only cleaning but also facility maintenance.

  • 1/3/24: From FDA: "We advised you of the whole genome sequencing (WGS) results via a conference call on January 3, 2024. You acknowledged that you had identified historical isolates of Salmonella Cubana in your facility since at least 2020. These findings may indicate that the same strain of Salmonella Cubana has survived since 2020."

➡ Asa comments: This unfortunately shows that this strain of Salmonella has been living in the facility for years. This likely could have been avoided.

  • 1/11/24: Company testing shows the Salmonella had migrated to an area of a production line without a kill step, and they issued a recall for all products made at that facility.

➡ Asa Comments: Issuing a recall of this level is costly, and from my inference of the information in this letter, it could have been avoided. Who is to blame? Usually, the plant manager or the head of quality makes the call to "keep going" rather than stopping production and conducting a comprehensive cycle of repairing, cleaning, and swabbing until the pathogen has been eradicated, but it is impossible to know what the culture of compliance broke down.

  • 4/3/24: The company decided to close manufacturing operations at this facility.

FDA goes on to share that the hazard analysis conducted at the facility after finding Salmonella in 2022 and 2023 was insufficient.

From FDA. "Furthermore, your corporate PEM program states that "repeat positive results typically indicate further deep dive," but you did not have any records indicating corrective actions beyond normal cleaning/sanitizing and maintenance (e.g., "deep dive" corrective actions) were taken at your facility."

There is more to this warning letter, and I suggest all executives, food safety, and quality teams read the letter as a case study of what can go wrong. At my consulting company Supplement Advisory Group, we do not focus on these matters, but if you need food safety support or GMP auditing, I would be happy to share my preferred contacts. 


Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.

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