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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?

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