Ten years of inspections at J.M. Smucker Companys production facility in Lexington, KY, leaves questions about how exactly Salmonella found its way into products and spread to consumers.
THIS MIGHT, the outbreak strain of Salmonella Senftenberg was within the J.M. Smucker Companys production facility in Lexington, KY.
On July 27, the CDC declared its investigation of the Salmonella outbreak linked to J.M. Smucker Co. over. It revealed 21 illnesses in 17 states. Four people required hospitalization no deaths were reported.
The real amount of sick people within an outbreak is probable much higher compared to the number reported, and the outbreak might not be limited by the states with known illnesses, based on the CDC. It is because lots of people recover without health care and so are not tested for Salmonella.
Whole Genome Sequencing (WGS) analysis showed that samples from sick people in this investigation are closely related genetically to an example collected in 2010 from the surroundings at J.M. Smucker Companys facility in Lexington, KY, where some Jif brand peanut butter is produced.
The analysis demonstrates this 2010 environmental sample matches any risk of strain causing illnesses in this current outbreak. Epidemiologic evidence indicates that Jif brand peanut butter stated in the J.M. Smucker Company facility situated in Lexington, KY, may be the likely reason behind illnesses in this outbreak, in accordance with a public alert issued by the meals and Drug Administration.
Food Safety News has obtained a lot more than 10 years of FDA and Kentucky Department of Public Health inspection reports for J. M. Smucker Company facility in Lexington, KY.
The FDA selects facilities for inspection predicated on risk. THE MEALS Safety Modernization Act, enacted in 2011, required FDA to immediately increase inspections of both foreign and domestic food facilities, including manufacturers/processors, packers, repackers, and holders of foods under FDA jurisdiction and mandated an inspection frequency, predicated on risk, for food facilities. All high-risk domestic facilities should be inspected within five years of enactment and at least one time every 3 years from then on.
FDA inspects food facilities to make sure food safety and compliance with regulations. During an inspection, FDA inspectors may identify potential violations of the meals, Drug, and Cosmetic Become well as other applicable regulations.
The question that must definitely be asked: was this salmonella outbreak the consequence of negligence for the J.M. Smucker Company facility? The violations cited below by federal and state at the facility through the years merit consideration.
FDA 08/31/2009 Establishment Inspection:
There have been no objectionable conditions observed and an FDA 483 form, Set of Observations, had not been issued.
There have been no objectionable conditions noted.
FDA 6/21/2010 Establishment Inspection:
Although no FDA 483 was issued, the next 4 observations were discussed with the firm. The four observations which were discussed with the firm at the close-out meeting:
1. A FDA inspector observed a worker leaving the production plant and cross the road to visit the BP Express to get something. This employee was wearing the business issued white smock, beard cover, bouffant hair cap, and shoe covers.
2. A FDA investigator and state inspector observed a worker use her fingers to attain inside fallen jars across the production line to create them upright.
3. A FDA inspector observed a worker getting into the (redacted) room from outside through the west door in building (redacted) and utilize the sanitation pan. The sanitation pan had not been positioned directly before this door. There exists a control panel left of the entranceway that delivers a walkway behind the panel from the entranceway in to the (redacted) room. The sanitation pan is situated in front of the control panel but to the proper enabling an open walkway between your panel and the sanitation pan.
The sanitation pan for the north outside door in building (redacted) was located left of the entranceway, leaving space between your doorway and the sanitation pan.
4. A wash station had not been located in the area with production line (redacted).
Two environmental samples for Salmonella were collected at the firm; INV549177 and INV549178. Two subs from INV549178 were reported positive with genus Salmonalle: sub 152 and sub 200. The firm reported that their swabbing sub 152 was also positive however they didn’t report that sub 200 was positive.
The FDA 484 was issued to Bill Erikson (William E. Erikson, Plant Manager) for both sample numbers, INV549177 and INV549178.
INV549178 sub sample 152 is situated in zone (redacted) across the wall at a doorway between your (redacted) room and the (redacted) room near a broom rack. FDA did get a telephone call from Bill Erickson who stated that the swab taken by JM Smucker personnel at exactly the same location also returned positive. His investigation found that the broom on the wall have been used outside and was then cut back inside.
INV549178 sub 200 is situated in zone (redacted) and was initially taken from the trunk side of a personnel fan in the warehouse. This is not deemed to be an instantaneous risk to the meals production. The corresponding JM Smucker swabbing had not been positive.
The firm has repositioned sanitation pans in building (redacted) so they are directly while watching doors.
The cleaning brooms through the entire facility should be destroyed and replaced with color coded brooms indicating they are to be utilized limited to food production areas and in the plant.
FDA 03/02/2011 Establishment Inspection:
A follow-up Obtain Inspections and Environmental Sampling for Salmonellae at Firm Producing Nut and CRAZY High Priority, DFPG #10-03 because of the previous salmonellae excellent results over the last EI (Establishment Inspection) 6/21-24/2010.
Although no FDA-483 Inspectional Observations was issued, four verbal observations were discussed with the firm by the end of the inspection. The observations were corrected and verified through the current inspection.
- Failure to keep up the piping and ceiling round the (redacted) and (redacted) room with ingredients in (redacted) systems free from excessive dust.
- Failure to keep Northwest corner and floor below stairs free from peanut spillage at the feeding side of roaster (redacted).
- Failure to keep floor of (redacted) system free from grease spillage close to roaster (redacted).
- Failure to seal small openings on warehouse shipping doors (redacted) and (redacted).
The firm seems to have an in depth Sanitation Standard Operation Procedure which outlined its (redacted) and (redacted) sanitation of equipment.
In accordance with Mr. Harter, Microbiological Lab Manager, the firm performs (redacted) environmental testing, rotates swabbing to different areas from zone (redacted). In accordance with Mr. Mahanes, the firm performs swab testing on peanut (redacted) and (redacted).
As well as the environmental swabs along with other pathogens, the firm also tests for aflatoxin for incoming products and during processing (redacted).
Mr. Mahanes stated that because the last two positive swabs from the final inspection on 6/24/10, the firm conducted a recall to see where in fact the positive may have result from and made changes with the addition of a fresh color coding system with new SOP for cleaning supplies (brooms). Furthermore, the firm added a fresh floor, sanitized the region, filled the ground with (redacted), (redacted), a flexi concrete material for cracks, re-swabbed before and after, placed new sanitation bath (redacted) (redacted) and supplied new broom for the region. The firm refused overview of environmentally friendly swabbing results, and wouldn’t normally share how many other pathogens were routinely monitored at the plant. When asked by way of a FDA investigator if there’s been any positive swabs, Mr. Mahanes also stated that the firm has already established zero excellent results for salmonella because the last FDA inspection on 6/24/10.
One environmental sample was collected from the firm; INV677913 contains sub samples 1-106 collected on 2/28/2011 one FDA 484 (Receipt for Samples) for the sample collected was issued to the firm 3/2/2011 through the close-out meeting. Two finished product samples were collected through the inspection: 677914 contains 12 18 OZ jars of Creamy Peanut Butter Jif brand with best buy date: March 2, 2013 and product code 1 039 423 19: 37 1 situated in row (redacted) within the warehouse, and 676629 contains 10 18 OZ jars of Crunchy Peanut Butter Jif brand, with best buy date: February 28, 2013, and product code 1 039 423 19: 37 1 situated in row (redacted) within the warehouse.
Finished product samples 677914 and 676629 were collected for aflatoxin sampling. Two FDA 484s for the finished product samples were issued to the firm on 3/2/2011 through the close-out meeting.
Commonwealth of Kentucky Department of Public Health
8/21/2012 Food Plant Inspection:
The firm comes with an environmental monitoring program with (redacted) swabbing by the product quality assurance group. The swabbing sites vary (redacted) and finished products are delivered to a third-party lab for analysis. The firm uses the laboratory (redacted) located at (redacted).
A master sanitation and cleaning schedule includes (redacted) and (redacted) activities. General cleaning and sanitation occurs each shift and is listed on a master sanitation program schedule. The firm utilizes (redacted) sanitizer on the (redacted) area for equipment that’s not portion of the (redacted) system. The (redacted) system equipment is known as the (redacted), is area of the clean-in-place approach and conducted (redacted). Finished product samples are taken soon after the cleaning process to make sure effectiveness.
The firm has previously installed a (redacted) foot bath ahead of entry in to the building so when entering different processing regions of the plant.
All plant employees were wearing uniforms, hairnets, beard nets (if applicable), hard-toed shoes, smocks, ear protection, and weren’t allowed jewelry or possess personal drinks in the processing, production, storage, or the areas where manufacturing had been conducted.
FDA 03/13/2015 Establishment Inspection Report:
One objectionable condition, a leaking roof, was observed and a FDA-483, Inspectional Observations was issued for failure to keep buildings in repair sufficient to avoid food from being contaminated, as rainwater was observed dripping in the corner of creating (redacted) a location used to store and clean (redacted) and (redacted) super sacks of raw peanuts. The leak was quickly repaired by maintenance.
No samples were collected.
Sanitation, housekeeping and cleaning appear adequate.
Quality control does collect, aseptically, (redacted) environmental swabs which can be anywhere through the entire facility, (redacted) who performs the analysis and the QA department with the outcomes.
FDA 2/28/2018 Establishment Inspection Report:
The establishment inspection on 2/28/2018 covered the manufacturing procedure for Jif Creamy Peanut Butter (Net WT 28 oz.), facility sanitation, interstate distribution and the firms HACCP plan.
Per the firm, (redacted) task sheets, all manufacturing equipment and food contact surfaces are cleaned and sanitized soon after or throughout production. All the major sanitizing procedures are conducted (redacted). Through the inspectional walk-through, a buildup of food and debris was observed accumulating on the lower of the protective cover on the manufacturing line (redacted).
On 2/28/2018, a closeout meeting happened at the firm and attended by Ellis W. Miller, Plant Manager, and John M. Lefevre, Manager of Quality Assurance, (redacted) Quality Specialist. FDA informed management that no inspectional observations were noted through the entire inspection, but discussed one deficiency at length.
- On 2/26/2018, An FDA inspector observed open jars of peanut butter being conveyed immediately below the protective cover of production line number (redacted) which contained an accumulation of food and debris. As FDA informed management of the concern, Mr. Ellis suspended production before manufacturing line was (redacted) cleaned.
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