Darwin’s QA program evolves in response to FDA enforcement measures

The following story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission.

Arrow Reliance Inc., dba Darwin’s Natural Pet Products, is taking steps to correct multiple violations of the Federal Food, Drug, and Cosmetic Act discovered during an investigation of Darwin’s raw pet food manufacturing facility in December 2017 and January 2018.

The Food and Drug Administration detailed the problems in a warning letter April 2.

A redacted copy of Darwin’s response letter was obtained by Food Safety News in response to a Freedom of Information Act request.

The investigation was triggered by a series of product recalls announced by the company in late 2017 due to Salmonella contamination in samples of Darwin’s raw frozen pet foods, following customers’ complaints of a kitten death and other ill pets. The joint investigation was carried out by the FDA and the Washington State Department of Agriculture (WSDA).

The FDA warning letter, and the Establishment Inspection Report that preceded it, highlighted several issues, including:

  • Bacterial pathogens (Salmonella, Listeria monocytogenes and/or E. coli O128) present in samples of various Darwin’s Natural Selections and ZooLogics brands of raw pet food;
  • The identical strain of Salmonella was recovered from both the dead kitten and a sample of food that had been fed to the kitten;
  • The protocol used by Darwin to reduce pathogen contamination through the application of bacteriophages had not been validated;
  • Failure to conduct operations under cGMPs (current Good Manufacturing Practices)
  • Raw materials not thawed under conditions that would minimize potential for growth of undesirable pathogens;
  • Animal food contact surfaces not made of appropriate materials or maintained to protect animal food from becoming contaminated; and
  • Equipment and utensils not used appropriately to avoid adulteration of animal food with contaminants.

In its response to the FDA warning letter, Darwin officials reported conducting a risk assessment to identify the root cause or causes of contamination. Based on the results of their assessment, the company concluded that the primary source of their contamination problem was pathogens present in some raw materials. 

To address that issue, Darwin has adopted new approaches to reducing or eliminating pathogens in those raw materials, including:

  • Requiring all meat suppliers and produce suppliers to use a pathogen-reducing treatment (details redacted) prior to shipping raw materials;
  • On-site audits of meat suppliers and primary produce supplier;
  • Pathogen testing conducted by an independent testing lab of a number of inbound raw materials;
  • Additional “interventions” that are being evaluated (details redacted) for possible inclusion in the company’s processes to further reduce pathogen levels;
  • Increasing the dosage of bacteriophages to match the manufacturer’s “standard” recommended dosage and tested a revised method of application; and
  • Conducting validation tests, which were carried out by an independent testing lab, to confirm the effectiveness of the higher bacteriophage dosage and revised application method.

According to Darwin’s response letter, in 2016, the company hired a Quality Assurance (QA) manager who developed the company’s first formal Standard Operating Procedures (SOPs) and Sanitation Standard Operating Procedures (SSOPs) and expanded the company’s sanitation and environmental testing programs. Prior to 2016, the sanitation and quality assurance functions were handled by the production department.

In response to the violations detailed in the FDA warning letter, the company expanded its QA team, adding an assistant manager and technicians. It also conducted a comprehensive review and update of its Good Manufacturing Practices (GMPs) conducted training sessions for employees, and corrected other issues raised by FDA and WSDA inspectors during the inspections initiated in December 2017 and completed in January 2018.

When asked to comment on the remedies outlined in Darwin’s response letter, a spokesperson for FDA said “… we aren’t able to share … any information about discussions with firms regarding their responses to warning letters.”

FDA’s investigation remains open, according to the agency spokesperson.

FDA gives Darwin’s pet food owners 15 days to clear up issues

Adulterated pet food, dead kitten, use of unapproved additive spur FDA warning letter

The FDA issued a formal warning letter to Arrow Reliance Inc. doing business as Darwin’s Natural Pet Products, citing pathogen problems at a production plant and saying scientific evidence shows the company’s cleaning solution is ineffective.

Darwin’s is a manufacturer of raw pet foods and is based in Tukwila, WA.

The April 2 warning letter from the Food and Drug Administration cites a history of consumer complaints and product recalls leading to the agency’s analysis of several Darwin’s products. Laboratory tests detected Salmonella, Listeria monocytogenes and E. coli O128 in one or more samples of the pet foods.

Foods under FDA jurisdiction, including pet foods, are deemed to be adulterated if they bear or contain a poisonous or deleterious substance that may render them injurious to health, according to the Federal Food, Drug, and Cosmetic Act (the Act). Introduction of an adulterated food into interstate commerce is a prosecutable violation of the Act.

Federal officials also found two Darwin’s products were also contaminated with Listeria innocua. Although it is not considered a pathogen in terms of human health, the warning letter underscored that the presence of Listeria innocua is an indicator that Listeria monocytogenes would be capable of surviving and growing in the product.

One of the consumer complaints that triggered the FDA investigation was lodged by the owner of a kitten that died as a result of a “severe systemic Salmonella infection” after being fed Darwin’s Natural Selections Duck Meals for Cats. 

Salmonella was isolated from the dead kitten’s liver and from an unopened raw pet food package. Whole Genome Sequencing (WGS) analysis, often referred to as genetic fingerprinting, confirmed that the Salmonella recovered from the dead kitten and from the pet food sample were identical.

FDA also performed WGS analysis on Salmonella recovered from various other Darwin’s samples. The identical Salmonella strain was found in two different products manufactured two weeks apart and containing two different meat sources. 

The presence of the identical Salmonella in these two products, according to the warning letter, suggests pathogen contamination in Darwin’s manufacturing facility.

In the letter, FDA also expressed its concern regarding Darwin’s use of a bacteriophage product to control pathogens in the raw pet foods, citing a lack of scientifically based validation of the controls and a change in the company’s protocol for applying the bacteriophage to the products.

The agency noted that the bacteriophage product is not “generally recognized as safe” (GRAS) nor is it the subject of a regulation describing additives permitted in animal foods.

The company was given 15 business days to reply to the warning letter, with a description of the steps taken to correct the violations and prevent these or similar violations from occurring in the future. 

This story first appeared in Food Safety News and is reposted here with permission.

Recalls and Alerts: March 25 – 28, 2018

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

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United States

Allergy Alert: First Source recalls Wegmans Yogurt Raisins (9-oz pkg; Best before 01/05/19; UPC 0 77890 31832 4) due to undeclared peanuts. The recalled product was sold in Wegmans Stores in MA, MD, NJ, NY, PA, and VA.

Allergy Alert: eBars LLC recalls various products due to undeclared peanuts and/or almonds. Please refer to the recall notice for a complete list of affected products, which were distributed through Whole Foods in Tennessee, Alabama, Mississippi, North Carolina, South Carolina, and Georgia, and through Kroger in Virginia, North Carolina, South Carolina, Mississippi, Texas, West Virginia, Michigan, Indiana, Tennessee, Alabama, Kentucky, Ohio, and Georgia, and were also distributed nationwide through ebars.com website.

Allergy Alert: Nine Whole Foods Market stores in Northern California recall some decorated (iced) cookies from the self-service cookie displays due to undeclared egg. Please refer to the recall notice for a list of affected products and stores.

Allergy Alert: Mrs. Gerry’s Kitchen Inc. recalls various salad products due to undeclared seafood. Please refer to the recall notice for a complete list of affected products.

Allergy Alert: Kwik Trip, Inc. recalls Kitchen’s Cravings Premium Egg Salad Sandwich on Oat Multigrain Bread (Sell by dates of 3/25/18, 3/26/18, 3/27/18, 3/28/18, and 3/29/18; UPC 3977900079) due to undeclared fish or seafood. The recalled product was sold in Iowa, Minnesota and Wisconsin.

Food Safety Recall: Tony Downs Food Company, Inc. recalls approximately 96,384 pounds of chicken products that may be contaminated with extraneous materials (hard plastic). Please refer to the recall notice for a complete list of affected products, which were distributed to retail stores nationwide.

Food Safety Recall: Tamarack Inc. recalls Eclipse Kratom-containing powder products due to possible Salmonella contamination. Please refer to the recall notice for additional details.

Food Safety Recall: Zappia Foods recalls various Zappia Marinara products because the products were manufactured without the benefit of inspection. Please refer to the recall notice for a complete list of affected products.

Pet Food Safety Recall: Blue Ridge Beef recalls BRB Complete Raw Pet Food (2-lb frozen chubs; Lot #GA0131) due to possible contamination with Salmonella and Listeria monocytogenes. The recalled product was distributed in Florida, Georgia, South Carolina, Tennessee and North Carolina.

Pet Food Safety Recall: Darwin’s Natural Pet Products recalls four production lots of its raw meals for dogs due to potential contamination with Salmonella and E. coli O128. Please refer to the recall notice for a complete list of affected products.


Outbreak Alert/Food Safety Recall: Erie Meat Products Ltd. recalls Druxy’s Fresh Deli Revolution brand Seasoned Cooked Roast Beef (variable weights; Best before 2018AL09) due to possible Listeria monocytogenes contamination. Please refer to the recall notice for a list of Druxy’s locations where the product was sold. CFIA advises the public that there have been reported illnesses that may be associated with the consumption of this product. Further lab testing is underway to confirm the link.

Outbreak Alert/Food Safety Recall: Erie Meat Products Ltd. recalls Harvest Creek brand Chicken Nuggets – Uncooked Breaded Cutlettes (2 x 1kg; Best before 18-OC-11; UPC 8 29810 93350 2) due to possible Salmonella contamination. The recalled product was distributed in New Brunswick, Nova Scotia, Newfoundland and Labrador, Ontario, and Quebec, and may have been distributed in other provinces or territories. The recall was triggered by findings by the Canadian Food Inspection Agency (CFIA) during its investigation into a foodborne illness outbreak. Information on the illness outbreak is available from the Public Health Agency of Canada.

Allergy Alert: Supermarché Samson P.A. (Laval, QC) recalls various ready-to-eat dishes due to undeclared sesame seeds, gluten, wheat, milk, soy, fish and eggs. Please refer to the recall notice for a complete list of affected products.

Allergy Alert: Phoenicia Group Inc. recalls Durra brand Mansaf Seasoning (70g; Lot 03; Best by 09/04/2019; UPC 6 251136 007096) due to undeclared sesame and gluten. The recalled product was distributed to retailers in Ontario and Quebec.

Allergy Alert: Metro Ontario Inc. recalls Irresistibles brand Swedish Style Meatballs, fully cooked (680g; all lots; UPC 0 59749 88417 4) due to undeclared gluten. The recalled product was sold in Ontario.

Allergy Alert: Industry recalls Dhawaka brand Choco Kids Chocolat en poudre (180g; Lot #107; Best before 07/2018; UPC 6 194023 504707) due to undeclared gluten. The recalled product was sold in Quebec.

Food Safety Recall: Restaurant le Palais Eagle (Montreal, QC) recalls Pain de poisson (all lots sold up to and including 23 March 2018) due to incorrect labeling (lack of instruction to keep product refrigerated).

Food Safety Recall: Marché Solaire (Montreal, QC) recalls Pain de poisson (all lots sold up to and including 23 March 2018) due to inadequate packaging and labeling (lack of instruction to keep product refrigerated).


Allergy Alert (Denmark): LikeMeat Nordic recalls Organic Veggie Chicken Style Chunks (180g; Best before 12/12/2018) due to undeclared soy.

Allergy Alert (Ireland): Lidl Ireland recalls Deluxe Wild Salmon with Dill Sauce and Deluxe Wild Salmon with Spinach (700g; All batches lacking English labeling) because the products contain allergens (gluten (Wheat), Egg, Fish, Milk, and Mustard) that are not indicated in English on the labels

Allergy Alert (UK): Interlink Direct Ltd recalls CEBU Dried Mangoes (100g; Best before 9 August 2019) due to undeclared sulphur dioxide and/or sulphites.

Allergy Alert (UK): Co-op recalls Co-op Breaded Cod Fillets (270g; Use by 02 April 2018) due to undeclared mustard and milk.

Food Safety Recall (Denmark): Valsemøllen A/S recalls organic rough rye flour (1kg; Best before 29/01/2019/12 and 12/02/2019/08) due to ochratoxin levels above acceptable limits.

Food Safety Recall (Denmark): Eksotiske delikatesser A/S recalls Aioli (160g; Best before 19/04/2018) due to Listeria monocytogenes contamination.

Food Safety Recall (Finland): Escamar Seafood Oy recalls Apetit Kirjolohisuikaleet (300g; Use by 28.3., 29.3. and 30.3.2018) due to glass breakage.

Food Safety Recall (Italy): Ittica Luciana S.r.l. recalls Clams (Tapes semidecussatus) (1 kg; Lot L570; Produced 18-3-2018 and 19-3-2018) due to presence of E. coli in excess of permitted levels.

Food Safety Recall (UK): AKM Foods Limited recalls Zaiqa GoGo Pan Masala Mouth Freshener products because they contain Rhodamine B. Please refer to the recall notice for a complete list of affected products.

Australia and New Zealand

Allergy Alert (Australia): Woolworths recalls WOOLWORTHS Macro Chinese Honey Soy Flavoured Tofu (200g; Use By 12 JUN 2018) due to undeclared peanuts.

Food Safety Recall (New Zealand): Go Farming Ltd recalls Go 2 Raw Milk brand raw (unpasteurized) drinking milk (1-L glass bottle; Batch Numbers 104, 105, 106, 107, 108 and 108b; Use by 19/3/18 to 28/3/18 inclusive) due to potential Campylobacter contamination.