FDA Bares Teeth. Kasel Flinches.

In case anyone hasn’t yet figured it out, the Mandatory Recall Authority that Congress granted FDA under the Food Safety Modernization Act was responsible for Kasel’s ‘voluntary’ recall of Salmonella-contaminated pet treats.

Earlier today, FDA released the letter in which the agency threw down its gauntlet and demanded that Kasel Associates Industries, Inc. recall contaminated pet treats. The  February 13, 2013 “Notification of Opportunity to Initiate a Voluntary Recall”, was hand-delivered to Raymond J. Kasel. The letter stated the basis for FDA’s determination that “…there is a reasonable probability that the affected pet treats are adulterated under section 402(a)(1) and (a)(4) of the FD&C Act and that there is a reasonable probability that the use of or exposure to the pet treats will cause serious adverse health consequences or death to humans or animals…” A sampling of the findings include:

  • Multiple finished product samples of Kasel pet treats obtained by the State of Colorado’s Department of Agriculture in September and October 2012, were tested and subsequently found to be positive for Salmonella.
  • In response to the state of Colorado’s Salmonella-positive results, FDA conducted an inspection of Kasel’s manufacturing facility from September 19-28, 2012. During the inspection, the FDA investigators collected various samples for further testing, including bulk and finished product samples and numerous environmental samples. Many of these samples tested positive for Salmonella.
  • Salmonella is a pathogenic organism that can cause serious adverse health consequences or death in humans and animals. The presence of Salmonella in pet food can pose a particularly acute health risk to children and people who are elderly or immunocompromised.
  • [E]vidence collected by FDA and the state of Colorado, including environmental and product samples collected and analyzed by Colorado and the FDA, and observations made by FDA during the inspection of [Kasel], establishes the following:
    • Pet treat products manufactured, processed, packed, or held by [Kasel] from April 20, 2012, through September 19, 2012, are contaminated with Salmonella, or are at risk for contamination with Salmonella, based on the conditions in your facility and multiple Salmonella-positive results from environmental samples, including positive results on food contact surfaces within your facility, and from samples of your finished product. Test results indicate there are more than a dozen different Salmonella serotypes in your firm’s manufacturing facility and finished products. In addition, the test results indicate that various Salmonella positive samples from finished products are serotype matches to, and in some cases share a Pulsed Field Gel Electrophoresis (PFGE) pattern with, other finished products and/or various environmental swabs taken at the facility during the September 2012 inspection. Due to this widespread Salmonella contamination and/or risk of contamination, FDA has determined that there is a reasonable probability these products are adulterated under section 402 of the FD&C Act and there is a reasonable probability that the use of or exposure to these pet treats will cause serious adverse health consequences or death to humans or animals.
    • [Kasel] created, caused or was otherwise responsible for this reasonable probability of adulteration: under section 402 of the FD&C Act. Specifically, FDA has determined that the conditions within your facility (e.g., the presence of Salmonella in various locations throughout the facility and multiple sanitation deficiencies) that could lead to cross contamination between raw materials and finished products caused the reasonable probability.”

The letter, which was signed by Michael R. Taylor (FDA’s Deputy Commissioner for Foods and Veterinary Medicine), demanded action within two (2) business days of its receipt by Mr. Kasel, and concluded with the following two statements:

“If you do not voluntarily cease distribution and conduct a recall in the time and manner described in this section, FDA may, by order, require you to immediately cease distribution of the affected pet treats. Additionally, FDA may, by order require you to immediately notify all persons manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling the affected pet treats to immediately cease distribution of such articles; and to immediately notify all persons to which such articles have been distributed, transported, or sold, to immediately cease distribution of the affected pet treats.”

“If a response is not received from you within two (2) business days of your receipt of this letter, FDA may by order require you to immediately cease distribution and notify applicable parties, as explained above.” 

The food and pet food industries are now on notice. FDA is ready, willing and able to use its mandatory recall authority to achieve the removal of dangerously contaminated food and pet food from the marketplace.

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?

Recalls and Alerts: December 7, 2012

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 current information on international and retail distribution of peanut butter products recalled due to Salmonella Bredeney, please consult the Trader Joe’s/Sunland Peanut Butter Recalls tab.

United States

  • Allergy Alert: Unilever recalls Knorr Pasta & Sauce Cheesy Bacon Macaroni (3.8 oz; UPC 4100008248; Sell by Sep1113BUO and Sep1213BUO), because the product may contain undeclared soy.
  • Food Safety Recall: Suzanna’s Kitchen (Duluth, GA) recalls Freebird Fully Cooked Chicken Nuggets (12 x 12-oz cartons/case; Case code 6220; Use by March 15, 2014; Julian code 2075), Freebird Fully Cooked Gluten Free/Soy Free Chicken Patties (12 x 12-oz cartons/case; Case code 6244; Use by September 6, 2013; Julian code 1249) and Fully Cooked Chicken Nuggets (10-lb bulk cases; Case code 6221; Use by March 15, 2014; Julian code 2075), because they may contain pieces of plastic. The bulk cases of Chicken Nuggets were shipped to a foodservice distributor in California for further distribution; the other recalled products were produced for a separate federally-inspected establishment and distributed to retail stores nationwide, including Whole Foods Market.
  • Pharmaceutical Product Safety Recall: Qualitest, a subsidiary of Endo Health Solutions, recalls Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Lot codes beginning with the letter “C”; NDC Numbers 0603-3888-16, 0603-3888-20, 0603-3888-02, 0603-3888-21, 0603-3888-22, 0603-3888-26, 0603-3888-04, 0603-3888-28, 0603-3888-32), because a number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for the ingredients of  hydrocodone bitartrate and acetaminophen.
  • Pharmaceutical Product Safety Recall: Bayer HealthCare’s Consumer Care division recalls BRONKAID Caplets Dual Action Formula (24 caplets; UPC300240537879; Lot Numbers NAA0B3T, NAA0BDB, NAA0B3P, NAA0B3R, NAA0B3N, NAA070E, NAA070F, NAA03PX, NAA03B5, NAA03B6, NAA02LT) and BRONKAID Caplets Dual Action Formula (60 caplets; UPC 300240537855; Lot Numbers NAA0TF3, NAA0TF2, NAA0TF0, NAA0TF1, NAA0TET, NAA0TEW, NAA0TEX, NAA0HHL, NAA0HHK, NAA0HHN, NAA0HHH, NAA0DK5, NAA0DK4, NAA0DK3, NAA0CHE, NAA0CHD, NAA0B3L, NAA0B3K, NAA09XE, NAA09XB, NAA07H2, NAA09XD, NAA07H1, NAA09XA, NAA09XC, NAA07H3, NAA07H4, NAA05BB, NAA05BA, NAA07H0, NAA070D, NAA070C, NAA03PW, NAA05B9, NAA070B, NAA03B8, NAA03B7, NAA02N1, NAA02LW, 244511P, 244501P, 244481P, 244471P, 244491P, 244451P), because certain information was not included in the BRONKAID Drug Facts labeling beginning in January 2012.
  • Dietary Supplement Safety Recall: LifeVantage Corporation (Salt Lake City, UT) recalls Protandim® the Nrf2 Synergizer®, dietary supplement (30 caplets/bottle; Lot #12-0258, 12-0259, 12-0292, 12-0294, 12-0295, 12-0304, 12-0306, 12-0307, 12-0373, 12-0382; Expiration Date 7/2/2015, 7/3/2015, 7/9/2015, 7/11/2015, 7/12/2015, 7/18/2015, 8/16/2015, 8/17/2015, 8/21/2015, 9/21/2015), because the product may contain small metal fragments.
  • Outbreak Alert Update: CDC reports that a total of 248 persons in 34 states have been infected with Salmonella (Salmonella Sandiego, Salmonella Pomona, Salmonella Poona) following contact with pet turtles or their environments.
  • Pet Food Safety Alert: FDA warns pet owners and caretakers not to feed pets Nature’s Deli Chicken Jerky Dog Treats (3-lb pkgs; Lot code BESTBY061913DEN), because the treats may be contaminated with Salmonella. The treats, which were manufactured, packaged and distributed by Kasel Associates Inc., were sold at Denver, Colorado area Costco stores. Kasel has declined to recall the product. Costco has removed all of the affected product from its store shelves.

Canada

  • Allergy Alert: Pure Indulgent Foods Inc. recalls Pure Chili Chocolate Mango Rich Chili Chocolate Cookies (300g; All codes; UPC 8 73376 00108 3) and Second Cup Chili Chocolate Mango Cookies (90g; all codes; UPC 8 73376 00008 6), due to the presence of undeclared milk. The recalled products were sold in Alberta.
  • Food Safety Recall: Taylor Shellfish Canada (Fanny Bay Oysters) recalls Salish Mussels brand Mussels (5 lb; Harvest date Dec 02/2012; Lot #7495), due to the presence of marine biotoxin. The recalled mussels were sold in Alberta and British Columbia.
  • Food Safety Recall: Cidrerie Michel Jodoin recalls Michel Jodoin Vista Bella Rosé – Sparkling Apple Must – No Alcohol (750 mL; Lot 1112; UPC 6 09780 01002 7) due to patulin contamination. The recalled product was sold in Quebec.

Europe

  • Allergy Alert (Ireland): The Food Safety Authority of Ireland warns consumers that Provitus Kurki (batch 12-2013-355), Podgryzybki (batch 12-2013-148) and Opienki (batch 05-2014-128) marinated forest mushrooms (250g jars; products of Poland) contain undeclared sulphites. The marinated mushrooms were sold in stores nationwide, mainly those selling Eastern European foods.
  • Allergy Alert (UK): Patriarche Wine Agencies recalls Chateau Le Bonnat Grand Vin de Bordeaux, Appellations Graves Controllee – Graves 2008 (75 cl), becaue the wine contains undeclared sulphites. The recalled wine was supplied to Co-operative stores.
  • Food Safety Recall (Denmark): ARDO A/S recalls Frigodan brand Pasta Pollo (600g; Packaged 25/8-2012; Best before 25/8-2013 and 28/8-2013), after a piece of a mouse’s head was found in a package of the product.
  • Allergy Alert Notification (EU #2012.1685): Undeclared sulphite in marinated mushrooms from Poland; distributed to France, Ireland, Poland and the United Kingdom.
  • Food Safety Notification (EU #2012.1687): Salmonella in spring onions from Thailand; distributed to Denmark.
  • Food Safety Notification (EU #2012.1689): Salmonella infantis in lemon grass from Thailand; distributed to Denmark.
  • Food Safety Notification (EU #2012.1690): Aflatoxins in shelled pistachios from Iran; distributed to Italy.

Australia and New Zealand

  • Food Safety Recall (Australia): Ontrack Pty Ltd. and Big W recall Truly Gifted Spice Rack 12 Bottle Spice Set (375g; Best before 30/11/2013), due to Salmonella contamination in the peppercorn portion of the product. The recalled product was distributed in Big W stores in ACT, NSW, TAS and VIC.

Latin America and the Caribbean

  • Food Safety Enforcement Action (Argentina): Government agents seized and destroyed 2,000 kilograms of foodstuffs in Córdoba after they were found to have been transported improperly.

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 web site.

*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.