FDA Warning Letter - RTE Salad Company

FDA issued a warning letter ready-to-eat RTE prepared foods manufacturing facility that produced RTE salads.  There are issues with the Preventive Control Plan as well as GMP issues.  One of the interesting items regarding their plan was that they were not following it.  Item number 3 below points out how many people write up a plan, and in that plan, they overstate what they do.

1) Listeria was found in the facility, the same strains of Listeria that were found in previous inspections - "FDA collected environmental samples from various areas of 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 strain found during FDA’s 2017 and 2018 inspections".  "Whole Genome Sequencing (WGS) of isolates detected in the FDA environmental samples identified six (6) isolates with the same strain of L. monocytogenes. Specifically, the same strain of L. monocytogenes was identified in three (3) isolates from environmental samples collected during the 2019 inspection, one (1) isolate collected from your facility in April 2018, and two (2) isolates collected from your facility in September 2017."

Because of this it can be stated that Sanitation Preventive Controls were not adequate -
The facility "identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard. However, as evidenced by environmental findings that indicate a resident strain of L. monocytogenes in your facility, you did not implement sanitation controls adequate to ensure that your facility is maintained in a sanitary"

2) FDA identified SSOPs that were not being followed - The company "did not implement the written sanitation control procedures identified in your SSOP entitled "

3) The company did not follow their own Supplier Preventive Controls - the Plan "states that Certificate of Analysis (CoA) “must be received prior to or on the date of ingredient delivery for all ingredients unless expressly exempted by Hans Kissle QA” and must contain “physical, chemical and microbiological test results for the specific lot number or code of the product.” It was observed that you do not receive CoA’s for RTE/refrigerated diced vegetables and RTE/refrigerated feta cheese that are used in the production of RTE Aegean Greek Pasta Salad. Although you indicated that you have an “exempt list,” these suppliers were not named on this list.  Additionally, no further kill step is applied to the diced vegetables and feta cheese in the production of RTE Aegean Greek Pasta Salad.  Note that when a hazard in a raw material or other ingredient will be controlled by the supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans, the appropriate default supplier verification activity is an onsite audit of the supplier"

4) GMP issue- Food stored directly on ground - "bags of RTE vegetables, including one (1) open bag of RTE carrots and one (1) torn bag of cucumbers, were staged on the floor of the hallway (b)(4) room.  This area was observed to be a high employee and equipment traffic area.  These bags of RTE vegetables are removed from their outer boxes in the hallway and placed onto plastic pallets or plastic totes adjacent to this area, (b)(4) was being washed and sanitized using (b)(4) that occasionally sprayed beyond the (b)(4) into the area where the vegetables were stored.

5) GMP issue - leaking valves through the facility - "during the most recent inspection of your facility, the following equipment conditions were observed in areas where there is significant handling of RTE product and employee movement"


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hans-kissle-company-llc-584080-09242019
WARNING LETTER
Hans Kissle Company, LLC
MARCS-CMS 584080 — September 24, 2019

Company Recalls Ham Sandwiches Due to Listeria Contamination.

Lipari Foods has issued a voluntary recall of Premo Ham & Cheese Wedge Sandwiches and Fresh Grab Ham & Cheese Wedge Sandwiches due to potential contamination of Listeria monocytogenes.   Lipari Foods is expanding its recall from 10/2/19 to include one lot of Ham & Cheese Wedge Sandwiches produced by JLM Manufacturing due to potential contamination of Listeria monocytogenes. The potential for contamination of this particular lot was brought to our attention during an FDA investigation of the previous recall.

The initial issue was the chicken used for chicken salad.  One could guess that during the FDA recall, they found that the ham sandwich product was packed in same area where the recalled chicken was handled and there was no complete clean step between handling the recalled product and the ham product.  Because of that, there would be the risk that the ham sandwich product became contaminated.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lipari-foods-issues-recall-ham-cheese-wedge-sandwiches-due-potential-contamination-listeria
Lipari Foods Issues Recall of Ham & Cheese Wedge Sandwiches Due to Potential Contamination of Listeria Monocytogenes
Summary
Company Announcement Date:  October 07, 2019
FDA Publish Date:  October 08, 2019
Product Type:  Food & Beverages  Prepared Food 
Reason for Announcement:  Potential contamination with Listeria monocytogenes
Company Name:  Lipari Foods
Brand Name:  Premo and Fresh Grab
Product Description:  Ham and cheese wedge sandwiches

This Week in Allergen Related Recalls for Week Ending October 5, 2019

Peanuts in Peppermint Ice Cream - Ample Hills Manufacturing of Brooklyn, New York is recalling all half pints of Peppermint Pattie Ice Cream (lot code 19169, all time stamps with Best by Date 6/18/20) (80z) (236ml) because they may contain undeclared peanut.   The recall was initiated after it was discovered that Peppermint Pattie ice cream (lot code 19169) containing peanut allergen was inadvertently discovered in a tub packaging and as a preventative caution, we are recalling all products made that day with that specific lot code as the ingredient statement on this ice cream does not reveal the presence of peanut allergen. Subsequent investigation indicates the problem was caused by a temporary breakdown in allergen control processes.

Label Missing Sulfites - Super World Trading Inc. of Brooklyn, New York is recalling 10 cases of 12 oz Dried Date with incorrect label as shown below, because it may contain undeclared sulfites.  The recall was initiated after it was discovered that product containing sulfite was distributed in packaging that did not reveal the presence of sulfite. Subsequent investigation indicates the problem was caused by a mislabeled in the packaging.

Undeclared Milk and Egg - RONG SHING NY Trading Inc. of Brooklyn, NY, is recalling its 6-ounce packages of GLAM DAY NOUGAT CANDY because they may contain undeclared milk and egg allergens.  The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of undeclared milk and eggs in the product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ample-hills-manufacturing-llc-issues-allergy-alert-undeclared-peanut-peppermint-pattie-ice-cream
Ample Hills Manufacturing, LLC Issues Allergy Alert on Undeclared Peanut in Peppermint Pattie Ice Cream

FDA Releases New Draft Guidance Chapter - Recall Plan

FDA released a new guidance document on 'recalls' as part of a series of chapters on the FSMA regulation. This new document titled - Chapter 14: Recall Plan provides FDA's current thinking on what you need to do when writing your company's recall plan.
That document can be found here - https://www.fda.gov/media/131287/download

It would be a good idea to review this document to ensure your current plan reflects what FDA states for each of the elements.

NIH Report - 40% Household Bleach Deactivates CWD Prions

A 5-minute soak in a 40% solution of household bleach (6% sodium hypochlorite) decontaminated stainless steel wires coated with chronic wasting disease (CWD) prions, according to a new study by National Institutes of Health scientists. The scientists used the wires to model knives and saws that hunters and meat processors use when handling deer, elk and moose – all of which are susceptible to CWD.

All bleach concentrations tested are based on undiluted Purebright brand bleach considered as 100%, which contains 6% sodium hypochlorite.   So a 40% solution was 20,000 ppm.

Link to study - https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0223659

https://www.nih.gov/news-events/news-releases/household-bleach-inactivates-chronic-wasting-disease-prions
Household Bleach Inactivates Chronic Wasting Disease Prions
Strategy Appears Feasible for Decontaminating Hunting, Meat Processing Equipment

Indiana Company Recalls RTE Pork Product After FSIS Samples Test Positive for LM

Fisher Packing Company, a Redkey, Ind. establishment, is recalling approximately 744 pounds of ready-to-eat (RTE) pork products that may be adulterated with Listeria monocytogenes.  The problem was discovered when the firm notified FSIS that a sample of product produced by Fisher Packing Company confirmed positive for the presence of Listeria monocytogenes.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-095-2019-release
Fisher Packing Company Recalls Ready-To-Eat Pork Products Due to Possible Listeria Contamination
Class I Recall
095-2019
Health Risk: High
Sep 28, 2019

Frozen Blackberries Recalled After FDA Testing Finds Norovirus

Cornerstone Premium Foods of Syracuse, New York is recalling a specific lot of product containing frozen blackberries (noted below) due to the potential of being contaminated with Norovirus. FDA testing of frozen blackberries was reported to have tested positive for Norovirus.

This is a concern because many will use berries in RTE applications, including making fruit smoothies.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cornerstone-premium-foods-voluntarily-recalls-frozen-blackberries-due-possible-health-risk-norovirus
Cornerstone Premium Foods Voluntarily Recalls Frozen Blackberries Due to Possible Health Risk of Norovirus
Summary
Company Announcement Date: October 04, 2019
FDA Publish Date: October 04, 2019
Product Type: Food & Beverages Fruit/Fruit Product
Reason for Announcement: Norovirus
Company Name: Cornerstone Premium Foods
Brand Name: Cornerstone
Product Description: Frozen Blackberries

King Arthur Expands Recall of Flour After Testing Finds E. coli Contamination

In association with ADM Milling Company, King Arthur Flour, Inc.,is expanding its recall to include specific lots of its Unbleached All-Purpose Flour (5 lb. & 25 lb.) after sampling found E. coli 026. King Arthur Flour has not received any confirmed reports of illnesses related to this product.  No illness have been reported.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/association-adm-milling-co-king-arthur-flour-inc-expands-recall-unbleached-all-purpose-flour-5-lb-25
In Association with ADM Milling Co, King Arthur Flour, Inc. Expands Recall of Unbleached All-Purpose Flour (5 Lb & 25 Lb)
Summary
Company Announcement Date: October 03, 2019
FDA Publish Date: October 03, 2019
Product Type: Food & Beverages Bakery Product/Mix
Reason for Announcement: E. coli O26
Company Name: King Arthur Flour, Inc.
Brand Name: King Arthur Flour
Product Description: Unbleached All-Purpose Flour

Company Expands Recall of Salmon Product Due to Listeria

A NY based company, Euphoria Foods is expanding a recall issued on 9/24/19 to now include all lots of the Captain K tuna product.  The initial recall was only for the lot that tested positive, but like many Listeria recalls, it is found that additional lots must be recalled because the production facility had inadequate controls for Listeria.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/euphoria-fancy-food-inc-recalls-capitan-k-salmon-fillet-due-possible-health-risk-update
Euphoria Fancy Food Inc Recalls “Capitan K Salmon Fillet” Due to Possible Health Risk Update
Summary
Company Announcement Date: October 02, 2019
FDA Publish Date: October 02, 2019
Product Type: Food & Beverages
Reason for Announcement: Listeria monocytogenes
Company Name: Euphoria Fancy Food Inc.
Brand Name: CAPITAN K
Product Description: Salmon slightly salted piece