Monday, April 3, 2017

SoyNut Co-packer, Dixie Dew, Slammed in FDA Inspection, Now Suspended

FDA suspended the food facility registration of the co-manufacturing facility of the Soy Nut Butter which was recalled for E. coli contamination.

CDC now reports that there are 29 cases of E. coli infection with 9 people developing HUS.  The majority of cases (83%) affecting people under the age of 18.

FDA inspected the facility (3/3/17 to 3/15/17)  at the same time the initial recall.  FDA issued a 483 report detailing issues in facility.
Here are some of the highlight from the 8 page report.  (For ease, a copy of this document is pasted below, this was converted from the pdf file)
  • The firm leaves product in the mix kettle overnight and over the weekend.
  • The mixing equipment just shuts off during processing, 1 or 2 times per day, and has had this problem for 15 years.
  • They do not calibrate their thermometer used for monitor the nut butter.  
  • The chart recorder also does not work.
  • During production of product, a clear liquid was observed dripping intermittently form a hole in the ceiling onto the floor and splashing on the equipment.  This was supposedly coming from a leaky pipe.
  • Product build-up  on floors and walls, and walking platforms. Standing water on floor.
  • Poor employee traffic flow as well as forklift flow, no restriction of movement from dirty areas /waste areas to processing areas.
  • Cleaning supplies not properly maintained.
  • Wooden pallets sitting in standing water.
  • Product piping system not disassembled since 2015, smaller pipes and filling not routinely cleaned.
  • Improper employee handwashing.
  • Pest control issues.
While this is clearly a co-packer issue, somebody had to approve this company.  Did the IMHealthy folks visit the facility?  Did they recognize the risk, especially considering who would be eating this product - children.  To me, they are just as responsible.

As part of the movement to small, unique brands, more and  more of these small brand companies are turning to co-packers to package their product.  This includes store brands as well.  There are risks however if these co-packers are not properly vetted and managed.  One of the key elements of FSMA, supplier preventive controls, was put in place to prevent this type of travesty.  (This is why I stick to my big brands with lots of food scientists and well developed QA/QC systems protecting that product).

FDA Safety Alerts and Advisories
FDA Suspends Food Facility Registration of Dixie Dew Products, Inc.
No food may leave the facility for sale or distribution
March 30, 2017

Fast Facts
  • On March 28, 2017, the FDA used authorities granted under the 2011 FDA Food Safety Modernization Act to suspend the food facility registration of Dixie Dew Products, Inc. (Dixie Dew) of Erlanger, Kentucky, because products manufactured in this facility may be contaminated. 
  • Soy nut butter manufactured by Dixie Dew has been implicated in an outbreak of E. coli O157:H7
  • The FDA’s decision to suspend the registration of Dixie Dew Products was prompted by the E. coli O157:H7 outbreak and the findings of FDA’s March 2017 inspection of Dixie Dew, which identified insanitary conditions that could lead to contamination with E. coli O157:H7 in finished products. 
  • No food can leave the Dixie Dew facility for sale or distribution while the food facility registration is suspended. 

What is the problem and what is being done about it?

On March 28, 2017, the FDA issued a Suspension of Food Facility Registration Order to Dixie Dew of Erlanger, Kentucky, after an inspection revealed insanitary conditions at the firm that could affect the safety of finished products.

The FDA inspected the facility between March 3 and 15, 2017. The inspection was conducted in response to an outbreak of E. coli O157:H7 in which many of those who became ill reported eating I.M Healthy SoyNut Butter products. The agency determined the soy nut butter in the products had been made by Dixie Dew, and identified Dixie Dew’s soy nut butter as the likely source of the outbreak. On March 3, 2017, Dixie Dew refused to allow FDA investigators access to the facility’s environmental sampling and production records; the FDA subsequently issued a Demand for Records under section 414 of the Federal Food, Drug, and Cosmetic Act. After receiving the Demand for Records, Dixie Dew provided FDA investigators with the necessary records.

At the close of the inspection, the FDA provided Dixie Dew with a list of the investigators’ inspectional observations (Form FDA 483), noting objectionable conditions seen during the inspection. Dixie Dew responded to the report in writing with a list of actions the firm has taken to correct the conditions; however, FDA found the corrective actions were not adequate to fully address the risks that were identified, and issued the Suspension Order to prevent further illnesses from occurring.

The Suspension Order applies to the entire facility. While the order is in effect, no food product may leave the facility for sale or distribution. The FDA will reinstate Dixie Dew’s food facility registration only when the agency determines that adequate grounds do not exist to continue the suspension of registration.

What are the symptoms of E. coli?

The symptoms of Shiga toxin-producing E. coli (STEC) from E. coli O157:H7 infections vary for each person but often include severe stomach cramps and bloody diarrhea. If there is fever, it is usually not very high (less than 101 degrees Fahrenheit/less than 38.5 degrees Celsius). Most people get better within 5–7 days. Some infections are very mild, but others are severe or even life-threatening.

Around 5–10 percent of those who are diagnosed with STEC infection develop a potentially life-threatening complication, known as hemolytic uremic syndrome (HUS).

Symptoms of HUS include fever, abdominal pain, feeling very tired, decreased frequency of urination, small unexplained bruises or bleeding, and pallor. Most people with HUS recover within a few weeks, but some suffer permanent damage or die. People who experience these symptoms should seek emergency medical care immediately. Persons with HUS should be hospitalized because their kidneys may stop working (acute renal failure), but they may also develop other serious problems such as hypertension, chronic kidney disease, and neurologic problems.

Nine patients in the ongoing outbreak have developed HUS.

Who is at risk?

People of any age can become infected. Children under the age of 10 and the elderly are more likely than others to develop severe illness, including HUS, but even healthy older children and young adults can become seriously ill. In this particular outbreak, the age range of ill patients is between 1 and 57 years, with a median age of 8 years.

Consumer Advice

All of the soy nut butter products manufactured by Dixie Dew have been recalled. Although the suspension of registration applies to the entire facility, FDA does not currently have evidence to indicate that any other products manufactured in the facility are contaminated or otherwise impacted and subject to recall.

Industry Advice

If you are the brand owner of a product manufactured by Dixie Dew, the FDA encourages you to contact the Director of Compliance Branch at your FDA district office to discuss your product(s). The FDA is currently collecting and testing other products manufactured by Dixie Dew.

FDA Form 483 (Inspectional Observations) for Dixie Dew Products, Inc.
Suspension of Food Facility Registration Order
FDA Investigates Multistate Outbreak of E. coli O157:H7 Infections Linked to SoyNut Butter
FDA 483 Report (converted from a PDF file)

Failure to manufacture and package foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.

A. Your firm does not conduct a kill step for SoyNut Butter product remaining in your firm's mixing kettle leftover from a production run. Your Plant Manager stated, up _____ may remain in the kettle overnight or weekend prior to resuming production. You and your Plant Manager stated the ____ the kettle is shut off when product remains in the kettle overnight and/or over the weekend.
B. According to your Plant Manager and Maintenance Supervisor, your _____machine, used for fine mixing of the SoyNut Butter and _____, routinely shuts off during processing.Your Plant Manager stated this occurs 1-2 times per day and, this problem has persisted for approximately 15 years despite repeated maintenance intended to correct the problem.
C. Your firm monitors the SoyNut Butter ____ with an ____ thermometer. Your Plant Manager stated he has never verified the accuracy of this instrument.
D. According to you and your Plant Manager, your temperature probe and chart recorder, initially engineered to verify and record ______ ' of product in the large mixing kettle, is not functioning properly and has not been used for well over a year.
E. During production of I.M. Healthy SoyNut Butter Creamy cups, Lot 065171on 3/6/2017, a clear liquid substance was observed dripping intermittently from a hole in a ceiling tile in your firm's Soy Butter Processing Room·and landing on the Processing Room floor and splashing on food manufacturing equipment below. The dripping liquid persisted throughout the duration of the production run which spanned from approximately ______,  According to you, the liquid was water from a leaking b pipe which hangs above the ceiling tiles.
F. The floors, walls, and ceilings in the Soy Butter Processing and Packaging Rooms are heavily coated with apparent old SoyNut Butter build-up from previous production runs. Additionally, standing water and brown and black apparent filth was observed on the Processing Room floor; particularly under equipment in hard to reach places and along the floor/wall junctures. Employee walking platforms used to access equipment during production were also observed to have a heavy coating of apparent old food residue and filth.

All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. .


A. Your firm does not have any employee or equipment traffic controls throughout the different operation areas of your firm, or between the facility and outdoors. Employees were observed walking throughout all areas of the facility including inside the boiler room, the exterior of the facility, bathroom s, and other areas outside the firm's different processing rooms. These same employees later walked into the Soy Butt er Processing and Packaging Rooms without any controls in place to minimize cross-contamination of the different areas of the facilities. Additionally, your firm has (6) mechanical forklifts, which operate throughout the interior facilities and outside the facility for waste disposal. These forklifts were observed moving in and out of your Soy Butter Processing and Packaging Rooms. On 3/13 / 2017, a green forklift was used to move processing waste from inside the facility to the firm's waste dumpster located· outside. The Plant Manager stated these forklifts are never cleaned.

B. On 3/8/2017, your cleaning supply cabinet was observed in disarray. Bathroom cleaning mops, brooms, and other cleaning equipment were intermingled an d in contact with similar cleaning equipment used to clean manufacturing equipment in processing rooms. The mop heads, brooms, brushes and other cleaning tools were in poor repair and covered in apparent old food residue. Many of the mop and broom heads were stained black from apparent filth .

G.The interior of the _____ bulk soy oil tote your firm used to manufacture the I.M. Healthy SoyNut Butter Creamy cups, Lot 065171 on 3/6/2017, was observed soiled with brown apparent residue. According to your Plant Manager, these totes are never cleaned. Additionally, the top port lid to the tote remained opened during the manufacturing and cleaning process on 3/ 6/ 2017.

H. A stack of wooden pallets were kept on the floor of the Soy Butter Processing Room. The lower pallets were sitting in water and were covered in apparent black mold and filth. These pallets were observed in this condition and location from 3/3/2017 - 3/9/2017.

I. The nozzle to the t(b ) ( 4) I and J(b ) (4) I in the Soy Butter Processing Room was observed laying on the Processing Room floor and in standing water multiple times during the inspection as well as during the manufacturing of I.M. Healthy SoyNut Butter Creamy cups, Lot 065171, on 3/6/2017.

J. On 3/6/2017, during production of I.M. Healthy SoyNut Butter Creamy cups, Lot 065171, the lid to the mixing kettle was stored propped up against the floor and wall of the Soy Butter Processing Room.

K. Various hand tools used to maintain production equipment in the Soy Butter Processing Room were stored on the floor and on employee walking platforms.

L. On 3/ 6/ 2017, stainless steel filling pipe was stored on the floor of the Soy Butter Packaging Room . You stated these filling pipes are no longer used and need to be discarded.


Hand-washing facilities lack running water of a suitable temperature.
Specifically, there was no hot water to the handwashing sink and the two compartment sink located in the Soy Butter Processing Room. According to your maintenance supervisor, the hot water tank for these sinks has been out 6f repair for two years. Additionally, the hand soap dispenser for the hand sink was not operable. Your Plant Manager stated he will sometimes use the (o} hose to wash his hands in the hand wash sink since th is is the only hot water in the room.
Failure to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing Specifically,

A. You and your Plant Manager stated you have not disassembled any SoyNut Butter processing equipment and all associated piping for cleaning and sanitizing since December of 2015.

B. Per your Plant Manager, your firm does not routinely wash and sanitize smaller pipes, pipe fit tings, gaskets, seals and the rubber (o} (plug) when broken down following a production run of SoyNut Butter. These are all food contact surfaces.

C. During a walkthrough of your Soy Butter Processing and Packaging Rooms on 3/3/ 2017, a substantial amount of dried apparent old SoyNut Butter residue from previous production runs was observed on food contact surfaces of the _____ large mixing kettle and ______. On 3/6/2017, apparent old SoyNut Butter was observed on the mechanical mixing arms inside the _____ of the 15oz jar filling machine. Additionally the _____ to this machine were also observed soiled with old SoyNut Butter food residue.

D. A substantial amount of dried apparent old SoyNut Butter residue from previous production runs coated non-food contact surfaces of processing equipment in the Soy Butter Processing and Packaging Rooms. According to you, the equipment is not routinely cleaned since the SoyNut Butter product cannot come into contact ______ ·. Additionally, old apparent SoyNut Butter residue heavily coated _____ control buttons and knobs, overhead electrical cables and ____ piping fixtures located throughout the Processing Room.

E. The SoyNut Butter cup conveyor belt used to convey packaged I.M. Health y SoyNut Butter Creamy cups, Lot 065171 on 3/6/2017, was visibly stained with apparent old SoyNut Butter residue.

Employees did not wash hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated.

Specifically, during production of I.M. Healthy SoyNut Butter Creamy cups, Lot 065:J.71 on 3/6/2017, an employee was observed handling manufacturing equipment which was in cont act with the process floor and proceeded to wash his hands in a handwash station without hand soap or hot water prior to continuing with the manufacturing process which involved handling packaged food ingredients and finished product containers and packaging.

Failure to perform microbial testing where necessary to identify possible food contamination.

Specifically, the buffer solutions and culture plates used by your firm to conduct internal coliform, APC and yeast and mold testing on your firm's finished products had expiration datesof 7/2016 and 10/2015 respectfully.

The plant is not constructed in such a manner as to allow floors and ceilings to be adequately cleaned and kept clean and kept in good repair. -

Specifically, the floors in the Soy Butter Processing and Syrup Rooms had missing tiles or were heavily pitted, cracked or in generai pdor repair throughout. Additionally, some ceiling tiles in the same rooms were observed misaligned or in poor repair i th holes and/or broken tiles. Furthermore, an approximate one foot opening between the outside of the walk-in refrigerator and warehouse room was observed along the back wall and floor of the unit. According to your Plant Manager, it was most likely caused by an employee moving a palletized prodUl t with a forklift.

Failure to provide adequate ventiation to minimize odors and vapors in areas where they may contaminate food.

Specifically, during production of I.M. HealthySoyNut Butter Creamy cups, Lot 065171 on 3/6/2017, a suspended haze was observed in the Soy Butter Processing and Packaging Room. According to your Plant Manager,the haze is created by the exhaust of theR6H 4 n machine and consists of a water and oil partic(1late mix. The lid to the large mixing kettle containing product was removed when this was observed.

Effective measures are not being taken to exclude pests from the processing areas.
A On 3/13/2017, an opened'(b)(4J bag in box (o) (4) product in your firm's walk-in cooler was observed with an apparent 3" diameter rodent defiled marking that penetrated the box and product. Additionally, apparent mold was growing on the surface of the butter.

B. An apparent fly infestation in your firm's Quality Control and Product Development Laboratory was observed on 3/13/2017. Small apparent flies and fly larvae, too numerous to count, were inside an unplugged chest freezer. A sealed blue plastic bag was inside the freezer and according to your Plant Manager, contained an egg product that became rotten when power was disconnected. The small apparent flies were observed along the laboratory counters and flying throughout the laboratory.

Failure to remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures.
Specifically, a heavy build-up of discarded SoyNut Butter and other products coated the internal surfaces of your firm's dumpster located on the exterior of the building near the loading dock. On 3/7/2017, the dumpsters side doors were open allowing easy access for pests.


3/03/20l?(Fri),3/06/2017(Mon);3/07/20 I ?(Tue),3/08/20l?(Wed),3/09/2017(Thu),3/l 3/20 l 7(Mon),3/ 15/

2017(Wed)                     ...

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