From the company responses as written in this Warning Letter, the company does not understand the fundamentals of Listeria control. As we have seen in so many cheese-related Listeria outbreaks, the lack of control can lead to serious consequences. Hopefully, this company is not back into production. These owners need to get some real education on Listeria control.
FDA findings, Company Response, FDA Response, Notes
Environmental swabs 18 of 50 positive for LM
3 of those positive samples were from food contact surfaces
- The top of the cheese slicer
- The cheese slicer string
- The inside of a plastic crate used to store finished cheese before packaging
One positive product sample - RTE feta cheese (FDA sample 969273).
1. There were a number of GMP violations found in the audit and addressed within the response.
, - the lift arm and bowl support brackets of the (b)(4) mixer contained areas which appeared to be rusted and contained rough surfaces.
- the beater shaft housing area of the (b)(4) mixer, directly above the bowl support brackets, was observed to contain areas which appeared to be rusted and contain food particulates and/or foreign matter. These areas are in close proximity and/or directly adjacent to food contact surfaces
- The floors in the processing room and walk-in cooler were observed to be in disrepair, containing areas where the concrete is cracked, rough, and peeling [see 21 CFR 110.20(b)(4)].
The company responded that they were doing the following.
a) A floor mop is now being used to clean the production floor.
b) (b)(4) is used to clean and sanitize the cheese cloths.
c) An apparatus has been purchased for storage of production equipment.
d) The production area hose is hung up and off the floor.
e) The office area has been cleaned.
f) The (b)(4) mixer has been cleaned, and the rusted surfaces have been repaired.
g) The floors of the processing room and walk-in cooler have been repaired.
FDA indicated that they will review these changes upon re-inspection,
Note - FDA did not ask the company for verification support to show that these changes had any impact on the Listeria contamination in the facility I see some issues here in the company responses 1) a floor mop to clean the production floor - really? That is more likely to spread Listeria - basically a contaminated swab...a very large swab. 2) How were the floors repaired? 3) How did they change their cleaning procedures - both daily for equipment and procedures for the facility?
2. Another area for concern was pest control. FDA listed these issues.
a) Greater than twenty flies landing on the floor, food processing equipment, food processing utensils, and other food contact surfaces and non-food contact surfaces.
b) Three fly catcher tapes containing multiple flies hanging in different areas of the processing room.
c) Dead flies on the window sills near the batch pasteurizer and three bay sink areas.
The company responded that the company 'installed “new fly catcher tapes . . . and will purchase a fly zapper.” FDA rightly noted that this corrective action is "inadequate because it does not prevent insects and/or other pests from entering the facility and does not address why the insects have entered your facility. The regulation at issue requires that pests be prevented from entering any area of a food plant and does not permit that pests be killed in close proximity of food production areas."
Note - Fly tape as a corrective action? Seriously? Who uses fly tape in a food production facility?
In the third item, FDA noted in their inspection that the grounds in which the facility was located had some major issues.
a) Live chickens and pigs coming within approximately one foot of the main door to the production facility and what appeared to be remnants of dead chickens and goats in close proximity to the production facility.
b) Multiple items within approximately twenty feet of the outside perimeter to your production facility which may constitute an attractant, breeding place, and harborage areas for pests, including, but not limited to, a chicken coop, an abandoned truck, a small four-wheeled loader, wood paneling, vegetation over six feet tall, and other small items which appear to be refuse.
The company's response stated that that they cleaned the area and added stone along the drive. However, they did not address the livestock and other animals in proximity to the production area and how those animals would be maintained. The company did not confirm that each item observed around the perimeter of your facility was addressed and corrected for FDA review.
Note - The company does not seem to understand the impact of contamination control from the grounds and the animals on those grounds. This is not only a concern for Listeria, but also for Salmonella and STEC E.coli.
FDA Warning Lettershttps://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm541240.htm
Apple Tree Goat Dairy 2/10/17