On March 18th, 2020, Cafe Valley executives received a warning letter from the Food and Drug Administration (FDA) about problems found during an inspection at their Marion, Indiana bakery.
These inspections started in November of 2019, and the letter, which was sent to CEO Brian Owens, points out that the bakery is in violation of many regulations set by the FDA.
FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Additionally, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility, including the same strains found during FDA inspections in 2018 and 2016.
The warning letter also says that they “determined the bakery products manufactured in your facility are adulterated… in that they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health.”
On January 6th, 2020, CEO Owens responded to the FDA with a letter, explaining the changes and improvements they were willing to adopt in order to address the problems found during the FDA inspections. However, the FDA was not convinced that the company was taking all necessary actions: the FDA found that Cafe Valley “did not implement sanitation controls adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes…”
The letter also points out that this has been a recurring issue, with the exact same pathogen having shown up in earlier inspections, in both 2016 and 2018. The letter said that the recurring presence of such a pathogen “demonstrates your sanitation efforts are inadequate.”
In the letter, the FDA did highlight one positive step that had been taken by Cafe Valley in an attempt to fix the problem: the bakery “voluntarily destroyed all croissant products produced between the cleaning performed before and after our environmental samples were taken.”
However, the FDA did not find that one action to be wholly sufficient and made recommendations for how the bakery should address the problem going forward.
It is essential to identify the areas of the food processing plant where this organism is able to survive and grow to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.
You should continue to implement the necessary methods and controls to ensure foodborne pathogens do not contaminate your RTE food products. Your record keeping will be critical to demonstrate your implementation of these corrections consistently over time.
If the bakery does not take sufficient action to prevent the spread of pathogens in its factory, the FDA says it “may result in legal action without further notice, including, without limitation, seizure and injunction.”
The FDA gave Cafe Valley fifteen days to respond in writing, to explain what changes they plan to make before the next inspection, but we do not have a copy of that response or know whether or not such a response was properly submitted.
Cafe Valley was also told that the FDA “will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspection.”
The warning letter from the FDA can be found, in its entirety, here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cafe-valley-bakery-llc-603875-03182020?fbclid=IwAR0dqohf0jjHqEj14hhDxGxMcw8lic9nytN8_nAo-GkP938NgMmAty2OexA