Repeat violations is a pretty good indicator of a food safety culture issue

My kids are terrible at remembering things. Everyday one of them forgets at least one of the following: homework; water bottle; to change his socks; to flush; brush their teeth.

There are many more.

As a parent it’s my job to keep reminding them – and it gets frustrating when the same things are done over and over.

But they are 8 and 10. And not running a food business. Their repeated mistakes don’t leave to foodborne illness risks for thousands of customers.

I read the FDA warning letters with fascination every time an email alert comes out. Today’s  highlight for me was that a food business, Reuben’s, cant seem to get stuff straight after repeated reminders from FDA inspectors. In 2005, 2008, 2009, 2016 and again last fall they had issues with facilities, pests and behaviors.

The investigators found the same stuff. That’s frustrating – and kinda shows that the business leadership doesn’t get it, or care.

When someone asks me about inspection results at a restaurant or a processor I tell them the limitations of the snapshot, what really matters is how has the business dealt with issues over time. Repeated issues without fixing shows a negative food safety culture in my books.

Here are some other highlights:

Several tiles were missing on the production floor. Water was pooling on the floor where tiles were missing/broken.

Chiles fell onto the dirty floor and were picked up by and placed into the rinse/cooling tank with other roasted chiles

Uncovered chile relleno products were observed in the walk-in freezer. The ceiling directly above the uncovered products displayed an accumulation of condensation drops and peeling paint.

We observed an employee push an uncovered rack of green chile from the walk-in refrigerator into the production area. The sides and top layer of green chile came in direct contact with an curtain which appeared to be soiled with red chile debris and grime.

I do love a good warning letter; here’s the Honey Smacks one

I love the FDA’s ongoing release of warning letters. This practice gives an insight into what’s happening in food facilities, especially important are the ones that are linked to outbreaks. FDA warning letters and 483 inspection forms have brought gold like us tugging at the dried skin of bearded dragons as well as scratching intergluteal clefts.

As the great Stefon says, the Kerry Inc./Honey Smacks warning letter has everything – pathogens, incomplete hazard analyses and poor sanitation. 

Some highlights:

Your hazard analysis did not identify a known or reasonably foreseeable hazard for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control as required by 21 CFR 117.130(a)(1).

Between September 29, 2016 and May 16, 2018, you repeatedly found Salmonella throughout your facility, including in cereal production rooms. During this time period, you had 81 positive Salmonella environmental samples and 32 positive Salmonella vector samples (samples taken in response to finding a positive on routine testing),

Further, you had repeated findings of other Salmonella species in some production lines and rooms used for the manufacture of cereal. These repeated findings of Salmonella in your environment should have resulted in a reanalysis of your food safety plan as required by 21 CFR § 117.170(b)(4) and the identification of contamination of RTE cereal with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation preventive control).

Washington company linked to Listeria monocytogenes illnesses gets a warning letter

Like my RSS feed notification for MMWR, FDA’s warning letter email alerts get me all excited about the potential treasures within. Like bearded dragons. And Whole Foods condensate issues.

Most telling are the letters that come after an outbreak investigation and that state almost 18% of environmental samples tested positive for Listeria monocytigenes (whoa).

FDA posted a warning letter to the Oregon Potato Company, AKA Freeze Pack, which was connected to CRF Frozen Foods outbreak.

FDA’s laboratory analysis of environmental samples collected on March 8, 2016, and March 9, 2016, confirmed that nineteen (19) of one hundred and six (106) environmental swabs tested positive for L. monocytogenes.Oregon_potato_Company

Specifically:

– Seven (7) positive environmental swabs were collected from direct food contact surfaces in both your Processing and Packaging Rooms during the production of your IQF diced onions. These direct food contact surface areas include:

o The chiller water and the interior north wall of the water chiller. Water from this chiller is not treated and is recirculated back to the blancher/chiller and used directly on blanched diced onions as a coolant;

o A white nylon strip in the tunnel discharge chute between the IQF freezer and the finished product Packaging Room. Blanched, finished product is conveyed and comes into direct contact with the nylon strip; and

o The metal arm on your chain conveyor belt between the IQF freezer and Packaging Room where blanched, finished product is conveyed directly on this conveying system and comes into contact with the metal arm.

– The remaining twelve (12) positive environmental swabs were collected from locations in your Processing room and your Packaging Room that were in areas adjacent to food contact surfaces and non-direct food contact surfaces.

WGS analysis was conducted on the nineteen (19) L. monocytogenes isolates obtained from the FDA environmental samples collected on March 8, 2016, and March 9, 2016. The WGS phylogenetic analysis establishes that there are at least two (2) different strains of L. monocytogenes present in the facility, with one strain containing seventeen (17) isolates and the second strain containing two (2) isolates. Specifically, the WGS analysis of the strain with 17 isolates showed that the isolates are identical to each other. WGS analysis of the strain with 2 isolates showed that the isolates are identical to 8 cases of human illness dating back to 2013, and to 6 isolates from finished products. These finished products included onions (2 isolates in 2014) and green beans (3 isolates in 2015) tested by a third party laboratory, and a single isolate from white sweet corn collected and tested by the state of Ohio in 2016. Additional investigation established that at least six (6) individuals were hospitalized as a result of related L. monocytogenes associated illness.

There’s a lot of cGMP Violations noted as well including cleaning and sanitizing issues, condensation dripping over IQF production lines and lots of niches for Listeria.