Thursday, May 7, 2015

FDA Inspectional Reports From Blue Bell Production Facilities

FDA published the inspectional observations from the Blue Bell production facilities in their three plants.  This comes after their product was linked to Listeria illnesses and product recalls.
Here is a list of finding, primarily the OK facility, but many of the same issue were identified in all three facilities.  It is important to remember that these facilities are producing a ready-to-eat product, and should be maintaining a high hygiene environment.  However these findings would not suggest high hygiene zones (or high care zones).

  1. Listeria was an issue in two of the three facilities.  It had been found on environmental swabs as well as  in products (3 products tested positive in the OK facility, 2 from TX) .
  2. In the testing plan, no food contact surfaces were tested.  They did not confirm past presumptive positive results.  They did not investigate as to whether they had an issue in product, and they did not investigate why they kept getting positives samples although they increased cleaning.
  3. They had consecutive positive samples at the same sites, so intensive cleaning was not always adequate.
  4. Condensation was a major issue and that condensation contacted food, food contact surfaces, and food packaging materials.
  5. CIP systems (Clean-In-Place) equipment not monitored adequately, not functioning to the required level (OK facility had hot water temperatures below required).
  6. There were occasions when employees failed to wash hands when they should have washed them.
  7. Employee shoes were not cleaned.  They did not have plant designated boots, something that is common to facilities that operate high hygiene zones.
  8. Wooden pallets were used throughout facility.  It appears that many were old pallets.
  9. Rough welds on food contact equipment, which would make cleaning to the microbiological level more difficult.
  10. Certain pieces of equipment were inadequately cleaned.  In the OK facility, this was due to improper teardown of equipment.  There were also building and equipment issues that made cleaning difficult.

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