WARNING LETTER
Arrow Reliance Inc
MARCS-CMS 547381 —
April 02, 2018
Delivery Method:
UPS Overnight Delivery
Product:
Animal & Veterinary
Recipient:
Recipient Name
Gary T. Tashjian
Arrow Reliance Inc
350 Treck Drive
Tukwila
,
WA
98188
United States
Issuing Office:
Center for Veterinary Medicine
United States
Seattle District Office
22215 26th Avenue SE, Suite 210
Bothell, Washington 98021
April 2 2018
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
In reply, refer to: WL CMS 547381
Gary T. Tashjian, President
Arrow Reliance Inc.
dba Darwin’s Natural Pet Products
350 Treck Drive
Tukwila, Washington 98188
WARNING LETTER
Dear Mr. Tashjian:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your raw pet food manufacturing facility in Tukwila, Washington, on December 6 through 7, 2017, and January 25, 2018, following customer complaints regarding your products.  In response to these customer complaints and during and after our inspection, FDA investigators collected samples of a number of raw pet food products from your customers and your manufacturing facility.  Analysis of these raw pet food products revealed they were contaminated with
Salmonella, Listeria
, and/or Shiga toxin-producing
Escherichia coli
O128.  Your raw pet food products are food under section 201(f) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(f)], because they are articles used for food for animals.  Based on the analytical results, these products are adulterated under section 402(a)(1) of the Act, which states that food is deemed to be adulterated if it bears or contains a poisonous or deleterious substance which may render it injurious to health.  The introduction or delivery for introduction into interstate commerce of an adulterated food violates section 301(a) of the Act [21 U.S.C. § 331(a)].  You may find the Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.
Adulterated Animal Food
Based on a consumer complaint received by FDA and your firm’s recall history, an unopened sample of Darwin’s Natural Selections Turkey with Organic Vegetables Meals for Dogs, lot 40507, manufactured on September 20, 2017, (FDA sample 441268) was collected by FDA on November 15, 2017, from one of your customers.  The sample was analyzed by an FDA laboratory on November 29, 2017, and was found positive for
Salmonella
.  An unopened sample of Darwin’s Natural Selections Chicken with Organic Vegetables Meals for Dogs, lot 40727, manufactured on September 26, 2017, (FDA sample 441270) was collected on November 15, 2017, from the same customer.  That sample was analyzed by an FDA laboratory on November 27, 2017, and was found positive for Salmonella and Listeria monocytogenes.  An unopened sample of Darwin’s Natural Selections Duck with Organic Vegetables Meals for Dogs, lot 40487, manufactured on September 29, 2017, (FDA sample 441269) was collected on November 15, 2017, from the same customer.  That sample was analyzed by an FDA laboratory on November 29, 2017, and was found positive for Salmonella.  You initiated a nationwide recall of these specific lots of products after FDA notified you of the sample results.  The FDA classified your recall as Class I, based on
Salmonella
and
Listeria monocytogenes
posing acute, life-threatening hazards to health.
Also, an unopened sample of Darwin’s ZooLogics Chicken Meals for Dogs, lot 41567, manufactured on November 2, 2017, (FDA sample 1031923) was collected by FDA on January 24, 2018, from one of your customers.  That sample was analyzed by an FDA laboratory on February 1, 2018, and was found positive for
Salmonella
.  An unopened sample of Darwin’s ZooLogics Duck Meals for Dogs, lot 41957, manufactured on November 16, 2017, (FDA sample 1031921) was collected by FDA on January 24, 2018, from the same customer.  That sample was analyzed by an FDA laboratory on February 6, 2018, and was found positive for Salmonella.  You initiated a nationwide recall of these specific lots of these products after FDA notified you of the sample results.  The FDA classified your recall as Class I, based on
Salmonella
posing an acute, life-threatening hazard to health.
Further, an unopened sample of Darwin’s Natural Selections Chicken with Organic Vegetables Meals for Dogs, lot 43887, manufactured on January 30, 2018, (FDA sample 1042721) was collected by FDA on February 28, 2018, from one of your customers.  That sample was analyzed by an FDA laboratory on March 19, 2018, and was found positive for
Salmonella
.  An unopened sample of Darwin’s ZooLogics Turkey Meals for Dogs, lot 44127, manufactured on February 4, 2018, (FDA sample 1042727) was collected by FDA on February 28, 2018, from one of your customers.  That sample was analyzed by an FDA laboratory on March 20, 2018, and was found positive for
Salmonella
and Shiga toxin-producing
Escherichia coli
O128.  An unopened sample of Darwin’s Natural Selections Duck with Organic Vegetables Meals for Dogs, lot 44147, manufactured on February 5, 2018, (FDA sample 1042728) was collected by FDA on February 28, 2018, from one of your customers.  That sample was analyzed by an FDA laboratory on March 16, 2018, and was found positive for
Salmonella
.  An unopened sample of Darwin’s ZooLogics Chicken Meals for Dogs, lot 44037, manufactured on February 7, 2018, (FDA sample 1042723) was collected by FDA on February 28, 2018, from one of your customers.  That sample was analyzed by an FDA laboratory on March 16, 2018, and was found positive for
Salmonella
. You initiated a nationwide recall of these specific lots of these products after FDA notified you of the sample results.
Public Health Impact of Pathogens
The presence of pathogens in pet food results in pet food being adulterated when the pathogen may result in adverse health effects to animals consuming the pet food and/or humans handling the pet food.
Salmonella
is a pathogenic bacterium that can cause serious and sometimes fatal infections in both humans and animals.  Pets like dogs and cats may get
Salmonella
infections from eating contaminated pet foods.  People may get
Salmonella
infections from handling these contaminated raw pet foods, or having contact with infected pets or their feces.  Infections can be especially serious in young children, elderly people, and others with weakened immune systems.  Healthy individuals, as well as pets, may suffer short-term symptoms such as severe diarrhea, bloody diarrhea, fever, chills, abdominal discomfort, and vomiting.  FDA considers a pet food to be adulterated when it is contaminated with any species of
Salmonella
.  In July 2013, FDA issued a Compliance Policy Guide (CPG) addressing the presence of
Salmonella
in Food for Animals, CPG 690.800, https://www.fda.gov/downloads/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm361105.pdf.
Listeria monocytogenes
is a pathogenic bacterium that is a known animal and human food pathogen posing an acute danger to human and animal health.  It can proliferate in animal food processing facilities without proper controls.  Handling or consuming these contaminated raw pet foods can lead to a severe, sometimes life-threatening illness called listeriosis, an atypical foodborne illness of major public health concern due to the severity of the disease, its high case-fatality rate, long incubation, and predilection for individuals with underlying conditions.  Healthy individuals as well as pets may suffer short-term symptoms such as vomiting, diarrhea, and fever.  However, more serious conditions such as meningitis may occur as well as abortion and death in severe cases.  Pregnant women are more susceptible to
Listeria monocytogenes
infection than are most other people, and although they generally recover, the infections can cause miscarriages, stillbirths, and preterm labor.  People with weak immune systems, including young children, the elderly, and immune-compromised individuals, also are more vulnerable to these infections.
Shiga toxin-producing
Escherichia coli
O128 (STEC) is a pathogenic bacterium that can cause serious illness in humans.  Handling or consuming raw pet foods contaminated with this pathogenic bacterium can lead to
Escherichia coli (E. coli)
infections.
E. coli
O128 is among the most clinically relevant Shiga Toxin Producing
E. coli
(STEC) in humans.
E. coli
O128 causes illness indistinguishable from
E. coli
O157:H7, and the symptoms include diarrhea, often with bloody stools.  Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS).  HUS is most likely to occur in young children and the elderly.  The condition can lead to serious kidney damage and even death.
E. coli
O128 is unknown to cause illness in dogs and cats, but infected dogs and cats can become carriers of
E. coli
O128 and transfer the
E. coli
O128 to the home environment.
Food Safety System
Unlike other human and pet foods which are heat-treated or are intended to be cooked, raw pet food has the potential to pose a significant risk to human and animal health because raw pet food is produced with minimal processing and is intended to be handled by humans and fed to animals without cooking, which would kill potentially harmful pathogens.  It is therefore essential that your firm has a food safety system in place to prevent and control contamination of your products and facility.  Aspects of such a system may include: proper implementation and review of cleaning and sanitization procedures, review and/or testing of your incoming materials and outgoing products, review and/or testing of your facility and environment for possible contamination, a kill step to destroy microorganism contamination, and root cause investigation and corrective action procedures when problems arise.  It is your responsibility to ensure that your procedures and overall system adequately prevent, control, and respond to contamination so that you are producing an unadulterated product.
You should take prompt action to correct the violations noted in this letter, and establish and implement procedures that will prevent these and other violations in the future.  Failure to implement lasting corrective actions may result in FDA taking further regulatory action, such as seizure and injunction, without further notice.
Additional Recalls and Sample Results
In September 2016, in response to a customer complaint of dog illnesses, you analyzed three lots of your raw pet food.  Darwin's Natural Selections Turkey with Organic Vegetable Meals for Dogs, lot 3142070, manufactured on July 20, 2016, was analyzed by your contract laboratory on September 24, 2016, and was found positive for
Listeria monocytogenes
.  Darwin's Natural Selections Beef with Organic Vegetables Meals for Dogs, lot 3146070, manufactured on July 21, 2016, was analyzed by your contract laboratory on October 4, 2016, and was found positive for
Listeria monocytogenes
.  Darwin’s ZooLogics Turkey with Vegetable Meals for Dogs, lot 3155070, manufactured on July 25, 2016, was analyzed by your contract laboratory on September 24, 2016, and was found positive for
Listeria monocytogenes
.  You initiated a nationwide recall of these specific lots of these products.  The FDA classified your recall as Class I, based on
Listeria monocytogenes
posing an acute, life-threatening hazard to health.
Also, in September 2017, in response to a customer complaint of a kitten death, you analyzed one lot of your raw pet food, Darwin's Natural Selections Duck Meals for Cats, lot 38277, manufactured on June 1, 2017.  This product was analyzed by your contract laboratory on September 19, 2017, and was found positive for
Salmonella
.  You initiated a nationwide recall of this specific lot of this product.  The FDA classified your recall as Class I, based on
Salmonella
posing an acute, life-threatening hazard to health.
On December 7, 2017, during an FDA inspection of your manufacturing facility, FDA collected two finished product samples; Darwin’s Natural Selections Chicken with Organic Vegetable Meals for Dogs, lot 42367, manufactured on December 6, 2017, (FDA sample 441272); and Darwin’s Natural Selections Duck with Organic Vegetables Meals for Dogs, lot 42787, manufactured on December 7, 2017, (FDA sample 441273).  These samples were analyzed by an FDA laboratory on December 23, 2017, and analysis found both samples positive for
Salmonella
, and Darwin’s Natural Selections Chicken with Organic Vegetable Meals for Dogs, lot 42367, positive for
Listeria monocytogenes
as well.  We acknowledge that at the time of our sampling of these lots of product, your firm placed the lots on hold pending notification from FDA of the sample results.  You reported that no portion of the lots had been distributed and the lots would continue to be held pending final disposition.  Although you did not distribute these lots, you should investigate the root cause of the contamination events and determine appropriate corrective actions.
Additionally, the presence of non-pathogenic
Listeria
species, such as
Listeria innocua
, is indicative of conditions that are suitable for the survival and/or growth of pathogenic
Listeria monocytogenes
.  Based on a consumer complaint received by FDA and your firm’s recall history, an unopened sample of Darwin’s Natural Selections Chicken with Organic Vegetables Meals for Dogs, lot 40727, manufactured on September 26, 2017, (FDA sample 441270) was collected by FDA on November 15, 2017, from one of your customers.  That sample was analyzed by an FDA laboratory on November 29, 2017, and was found positive for
Listeria innocua
.  Further, a sample of Darwin’s ZooLogics Chicken Meals for Dogs, lot 41567, manufactured on November 2, 2017, (FDA sample 1031923) was analyzed by an FDA laboratory on February 1, 2018, and was found positive for
Listeria innocua
.  A sample of Darwin’s ZooLogics Duck Meals for Dogs, lot 41957, manufactured on November 16, 2017, (FDA sample 1031921) was analyzed by an FDA laboratory on February 6, 2018, and was found positive for
Listeria innocua
.
Whole Genome Sequencing
In addition to these lots of your raw pet foods being contaminated with a variety of bacterial organisms, a customer provided information to FDA that
Salmonella
was isolated from both a deceased kitten and from an unopened package from the same lot of the raw cat food consumed by the kitten, specifically Darwin’s Natural Selections Duck Meals for Cats, lot 38277, manufactured on June 1, 2017.  The kitten necropsy indicated a severe systemic
Salmonella
infection, and
Salmonella
was isolated from the kitten’s liver.
Whole Genome Sequencing (WGS) analysis was conducted on these
Salmonella
isolates from the kitten and the unopened raw pet food package, as well as other
Salmonella
isolates obtained from your raw pet foods.  WGS analysis of bacterial pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness.  WGS data can also be used to infer the evolutionary relationships (or phylogeny) within a given set of isolates as it characterizes each DNA position in a bacterial genome.
WGS analysis shows that the
Salmonella
found in the kitten liver was identical to the
Salmonella
isolated from the same lot of raw cat food consumed by the kitten.  This analysis indicates that your product may have caused the illness and death of the kitten.
Also, the FDA performed WGS analysis on Salmonella strains obtained from your raw pet foods, including Darwin’s ZooLogics Chicken Meals for Dogs, lot 41567, manufactured on November 2, 2017, (FDA sample 1031923); and Darwin’s ZooLogics Duck Meals for Dogs, lot 41957, manufactured on November 16, 2017, (FDA sample 1031921).  Although the meat sources for these two products are different, the WGS analysis indicates that these
Salmonella
strains are identical, which may suggest pathogen contamination in your facility.
Use of Bacteriophage
During a conference call between FDA and your firm on February 7, 2018, you indicated that your firm uses bacteriophage to reduce the pathogens in your raw pet foods.  You stated that you have changed your protocol for applying the bacteriophage to your product; specifically, that you have increased your application of the bacteriophage.  FDA notes that controls implemented should have scientifically based validation to ensure they effectively eliminate the pathogens in pet foods intended for distribution.  These validated controls should also ensure the control of pathogens in the facility in which the controls are implemented.  In addition, we have concerns about the use of these bacteriophage because we are unaware that they are generally recognized as safe, as described in Title 21, Code of Federal Regulations (21 CFR) 570.30, or the subject of a food additive regulation published in 21 CFR Part 573, describing food additives permitted in animal foods.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter describing the specific steps you have taken to correct the noted violations, and to prevent these violations from recurring or other similar violations from occurring.  You should include documentation of corrective actions you have taken to date.  If your firm will not be able to complete corrective actions before you respond, please state the reason for the delay and include a timetable for implementation of those corrections.
Your written response should be sent to:  U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of LCDR Cynthia White, Compliance Officer.  If you have questions, you may contact LCDR White at (425) 302-0422.
Sincerely,
/s/
Miriam R. Burbach
District Director
Program Division Director
cc:  Washington State Department of Agriculture
Food Safety Program
1111 Washington Street SE, 2nd Floor
Olympia, Washington 98504-2560
Content current as of:
04/03/2018
Regulated Product(s)
Animal & Veterinary