Tag: Salmonella

Kasel Inspection Report: Roaches and Rodents and Filth. Oh My!

FDA has released its Inspectional Observations report (Form 483) covering the issues encountered during the agency’s September 19 – 28, 2012 inspection of the Kasel Associates Industries, Inc. manufacturing plant in Denver.

Last week, Kasel recalled a range of pet treats manufactured from April 20, 2012 through September 19, 2012 due to potential Salmonella contamination. As I reported yesterday, FDA found 14 different Salmonella strains in finished product and environmental swab samples taken at the company’s manufacturing facility during the September 2012 inspection.

FDA’s 9-page report documents improper sanitation throughout the facility, inadequate pest control – including live and dead cockroaches, rodent droppings, flies and a dead mouse – improper food storage, improper handling of work-in-progress, and inadequate maintenance. Following is just a sampling of the deficiencies:

OBSERVATION 1. Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food, food–contact surfaces, and food-packaging materials.

  • Food debris build-up on and underneath conveyor belts on packing lines
  • Food and grease build-up on metal crates used to hold finished product before packaging
  • Finished, unpackaged bulk product stored in grease-laden and reused cardboard totes
  • Floor fan with accumulated dust and grease was blowing onto uncovered bulk bins of unpackaged finished product

OBSERVATION 2. Effective measures are not being taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests.

  • Larvae-like inspects on floor drain of Cutting Room
  • Live and dead cockroaches in numerous areas, including the Packaging Room, Bulk Storage Room and Preparation Room
  • Large flies (live and dead) in the Packaging Room
  • Dead mouse in Bulk Storage Room partially under pallet of finished product
  • Rodent excreta pellets in the General Storage Room near pallets of finished/packaged products

OBSERVATION 3. Failure to take effective measures to protect against the inclusion of metal and extraneous material in food.

  • No functioning metal detector on packaging lines
  • Wooden pallets with chipping wood and loose nails stored directly on top of uncovered bulk bins of finished product
  • Metal fragments in direct contact with chicken chips on drying racks

OBSERVATION 4. Failure to take effective measures to protect finished food from contamination by raw materials.

  • Plastic tubs used in both raw production and finished product packaging to hold both raw and finished product; no system in place to differentiate which tubs were used for which purpose
  • No dedicated washing equipment or system to wash, rinse and sanitize the plastic tubs

OBSERVATION 5. Failure to store finished food under conditions that would protect against physical and microbial contamination.

  • Finished product stored uncovered in bulk bins
  • Finished product stored in unlined wire bulk crates in direct contact with floor

OBSERVATION 6. Failure to handle work-in-progress in a manner that protects against contamination.

  • Uncovered pallet of frozen chicken stored on loading dock while employees loaded a truck with loading dock door open
  • Floor sanitizer foam sprayer (label states chemical unfit for human or pet consumption) observed spraying onto uncovered bulk pallet of frozen chicken chips

OBSERVATION 7. Failure to maintain buildings, fixtures, and physical facilities in repair sufficient to prevent food from becoming adulterated.

  • Floors not sealed: grease accumulation in cracks and exposed concrete, visible chipping paint
  • Broken, taped and swollen ceiling tiles above filling lines and throughout Packaging Room
  • Broken and missing light shields
  • Hand sinks in Preparation Room not functioning

OBSERVATION 8. Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated.

  • Employees observed not washing hands after leaving rest room or break room

Is it any wonder that Salmonella ran rampant throughout this facility?

FDA Flexes Muscles To Achieve Kasel Pet Treat Recall

The extensive ‘voluntary’ pet treat recall announced on February 19th by Kasel Associated Industries (Denver, CO) was triggered by FDA’s threat to invoke its new mandatory recall authority, according to Siobhan DeLancey, spokesperson for FDA’s Office of Foods and Veterinary Medicine.

Earlier today, DeLancey informed eFoodAlert by email that Kasel chose to voluntarily recall its products upon receipt of a “last chance” letter from FDA (formally, a Prehearing Order to Cease Distribution and Give Notice, also referred to as a 423(a) letter). This is the first time that FDA has initiated mandatory recall proceedings under the authority granted to it by the Food Safety Modernization Act.

FDA inspected Kasel’s manufacturing facility during a 10-day period beginning September 19 2012, after the Colorado Department of Agriculture found Salmonella in a finished product sample of Boots & Barkley 6-count 5-inch American Beef Bully Sticks. Kasel recalled four lots of the product on September 21st (Lots #BESTBY20APR2014DEN, BESTBY01JUN2014DEN, BESTBY23JUN2014DEN, and BESTBY23SEP2014DEN). On October 2nd, the company recalled Nature’s Deli Chicken Jerky Dog Treats (2.5 lb; Lot #BEST BY 091913 DEN) after FDA found Salmonella in a sample of this lot code. Additional testing carried out by Colorado prompted a third recall on October 17th, this time of Boots & Barkley Roasted American Pig Ears and Boots & Barkley American Variety Pack Dog Treats (Lot #BESTBY 13SEP2014DEN for both products). Colorado found Salmonella in another retail sample of Nature’s Deli Chicken Jerky Dog Treats (Lot #BESTBY061913DEN) in November 2012; however, Kasel refused to initiate another recall.

The September 2012 inspection carried out by FDA revealed several sanitary issues, including live insects and evidence of rodent activity in the manufacturing facility, DeLancey said. Furthermore, FDA recovered Salmonella from all of the finished product samples collected during its inspection, as well as from 1 out of 2 in-process bulk product samples and 48 of 87 environmental swab samples. Some of the Salmonella-positive swab samples were taken from food contact surfaces. In all, FDA found 14 different strains of Salmonella: Anatum,  Mbandaka,  Senftenberg,  Typhimurium, Agona,  Muenchen, Irumu,  Tennessee, Montevideo, Infantis, Muenster, Derby, O rough;d;e,n,x,  and London. Isolates recovered from products made on June 19th matched those from September 19th, indicating an ongoing contamination issue.

FDA carried out a follow-up inspection on February 14, 2013, including additional finished product and environmental swab sampling. Results of those samples are still pending; however, FDA noted that the company had taken several corrective measures.

I found it strange that the latest recall covered only the period from April 20, 2012 through September 19, 2012. DeLancey explained that this was the time frame during which positive results were collected. If FDA finds additional Salmonella-positive samples as a result of its follow-up inspection, I would expect either an expansion of the most recent recall or – in the event that Kasel proves recalcitrant – another FDA-issued warning.

FDA has received a “small number” of complaints from pet owners whose dogs became ill after being exposed to the recalled treats. No human illnesses have been reported yet.

eFoodAlert Advice to Consumers

  • Check your supply of pet treats against the products listed in the most recent recall notice. Discard any that are mentioned on the list. If you are not sure of the origin or lot code of the treat, discard it.
  • If your dog develops symptoms of a Salmonella infection (typically diarrhea or vomiting) after consuming a Kasel-manufactured treat, seek veterinary attention; also, report the illness to FDA.
  • If you or a family member develop symptoms of a Salmonella infection after handling a Kasel-manufactured pet treat – or a sick pet – seek medical attention, and mention the possible link to the pet treat.
  • Always wash your hands immediately after handling any pet food or pet treat, especially one of the affected brands listed in the recall notice.

If you believe that your pet or a member of your household has become ill as a result of exposure to one of the brands of pet treat mentioned in the recall notice, please post a comment.

Recalls and Alerts: February 22, 2013

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.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

For up-to-date information on recalls and product withdrawals associated with the horse meat investigation, please consult the Horse Meat Synopsis and Recalls page.

United States

  • Allergy Alert: Bruce Foods Corporation (New Iberia, LA) recalls Food Club Red Enchilada Sauce (10 oz can; Code GES 462449; Best before 12/3/2016), because the cans may contain Green Enchilada Sauce instead of Red. The Green Enchilada Sauce contains wheat and soy, which are not indicated on the labels of the Red Enchilada Sauce. The recalled product was supplied to retailers in Virginia and Minnesota between 1/15/2013 and 1/16/2013.
  • Food Safety Recall: GoldCoast Salads (Naples, FL) recalls Blue Crab Spread (1-lb & 8-oz containers; EXP 21/14/13 B), Maine Lobster Spread (1-lb & 8-oz containers; EXP 2/16/13 LA), Lobster and Shrimp Spread (1-lb & 8-oz containers; EXP 2/23/13 L&S1 and EXP 3/30/13 L&S1), and Smoked Salmon Spread (1-lb & 8-oz containers; 3/10/13 S2), due to possible Listeria contamination. The recalled products were supplied to stores in the North East and South East USA.
  • Pet Food Safety Recall: The Honest Kitchen recalls Verve pet food (4 lb & 10 lb box; Item code V4 + VR; Production date 8/20/12; Expiry 8/20/13; Lot #2332A, batches 1-3), Verve pet food (10-lb box; Item code VR; Production date 11/1/12; Expiry 11/1/13; Lot 3062A, batches 8 & 9), Thrive  pet food (1 oz sample; Item code TM; Production date 9/18/12; Expiry 9/18/13; Lot 2622A, batch 3), Zeal pet food (4 lb & 10 lb box; Item code Z4 + ZR; Production date 8/14/12; Expiry 8/14/13; Lot 2272A, batches 1-5) and Zeal pet food (10 lb box; Item code ZR; Production date 9/21/12; Expiry 9/21/13; Lot 2652A, batches 1-4), due to potential Salmonella contamination. The recalled products were sold across the USA and Canada.
  • Pet Treat Safety Recall Update: Kasel Associates Inc. recalls all pet treats manufactured from April 20 through September 19, 2012 due to potential contamination with Salmonella. FDA has received a ‘small number of complaints’ of illness in dogs who were exposed to these treats. During a follow-up inspection at the firm, FDA sampled finished pet treat products and the environment for Salmonella. All of the pet treat products and 48 of the 87 environmental samples tested positive for Salmonella. The agency found more than 10 different Salmonella in the products and the manufacturing facility. Because of the multiple positive tests for Salmonella, and the production practices and conditions observed at the facility during the inspection, FDA believes that there is a reasonable probability that pet treat products manufactured in the facility from April 20, 2012 through September 19, 2012 are contaminated with Salmonella. Affected brands include Boots & Barkley, Petco, Kasel, Menards, Target, Nutri-Vet, Nature’s Deli (Sam’s Club and Costco), and TDBBS Inc. Best Bully Sticks.
  • Food Safety Enforcement Action: FDA enters into consent decree with U Joo Foods, a sprout grower located in Chicago. Under the consent decree, U Joo Foods is prohibited from processing and distributing food until they demonstrateto the FDA that the facility and processing equipment are suitable to prevent contamination in the food that they process, prepare, store, and handle.  In addition, they must routinely test the water where the sprouts are grown for evidence of contamination.

Canada

  • Pet Food Safety Recall: The Honest Kitchen recalls Verve pet food (4 lb & 10 lb box; Item code V4 + VR; Production date 8/20/12; Expiry 8/20/13; Lot #2332A, batches 1-3), Verve pet food (10-lb box; Item code VR; Production date 11/1/12; Expiry 11/1/13; Lot 3062A, batches 8 & 9), Thrive  pet food (1 oz sample; Item code TM; Production date 9/18/12; Expiry 9/18/13; Lot 2622A, batch 3), Zeal pet food (4 lb & 10 lb box; Item code Z4 + ZR; Production date 8/14/12; Expiry 8/14/13; Lot 2272A, batches 1-5) and Zeal pet food (10 lb box; Item code ZR; Production date 9/21/12; Expiry 9/21/13; Lot 2652A, batches 1-4), due to potential Salmonella contamination. The recalled products were sold across the USA and Canada.

Europe

  • Food Safety Recall (Germany): Minderleinsmühle GmbH & Co. KG recalls Linseed (25kg, 1000g and 500g packs; Best by 31.08.2013, 31.10.2013, 30.11.2013 and 07.12.2013) due to consumer complaints of foreign bodies in the products.
  • Food Fraud Withdrawal (Belgium, Ireland, Netherlands, UK): Iglo withdraws all meat products manufactured by Frigilunch N.V. (Belgium) after Iglo Chili Con Carne tests positive for horse DNA at 2%. Affected products were sold under the Iglo and Birds Eye brands.
  • Food Fraud Withdrawal (Ireland): Birds Eye withdraws all batch codes and dates of Beef Lasagne, frozen (400g), Traditional Spaghetti Bolognese, frozen (340g) and Shepherd’s Pie, frozen (400g), after the detection of horse DNA in a chilli con carne product manufactured at Frigilunch N.V. (Belgium) for Birds Eye. The chilli con carne was sold only in Belgium.
  • Food Safety Notification (EU #2013.0223): Norovirus in chilled oyster from France; distributed to Italy.
  • Food Fraud Notification (EU #2013.0224): Suspicion of fraud (horse DNA) in relation to penne bolognese from Germany; distributed to Austria.
  • Food Safety Notification (EU #2013.0226): Salmonella in chilled boneless pork meat from Spain; distributed to Finland.
  • Food Safety Notification (EU #2013.0228): Salmonella Heidelberg in frozen chicken meat from Brazil; distributed to Italy.
  • Food Safety Notification (EU #2013.0229): Folpet in batavia lettuce from France; distributed to France.
  • Food Safety Notification (EU #2013.0230): Plastic fragments in frozen diced red peppers from Poland; distributed to Germany.

Asia, Africa and the Pacific Islands

  • Proprietary Chinese Medicine Recall (Hong Kong): Dragon Ginseng Enterprise (HK) Limited recalls Dragon Ginseng Flavon”, “Dragon Ginseng Sapon”, “Dragon Ginseng Ginseng Powder (50 sachets per box)” and “Dragon Ginseng Ginseng Powder (two bottles per box)”, because the medicines are believed to be unregistered.

Australia and New Zealand

  • Allergy Alert: Koala Popcorn Pty Ltd. recalls Koala Popcorn Chicken Flavour (25g net; All best before dates up to and including 07.07.13), due to undeclared milk. The recalled product was available in school canteens and via a small number of vending machines.

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket’s recall website.

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.
**Includes Safeway, Vons, Pavilions, Dominick’s, Genuardi’s, Randalls, Tom Thumb, Carrs and Pak N’ Save.