After inspecting the Danville Plant on 06/18/2009(Thu), 06/19/2009(Fri), 06/22/2009(Mon), 06/23/2009(Tue), 06/24/2009(Wed), 06/25/2009(Thu), 06/26/2009(Fri), 07/07/2009(Tue), 07/08/2009(Wed), and 07/09/2009(Thu), the FDA posts a 1, yes, 1 page "483" online last night, or early this morning – yes, even I sleep sometimes.  Here are the 2, yes, 2 Observations.  Looks like I am heading to Danville soon.


The workmanship of equipment does not allow proper cleaning.  Specifically, inside the "Toll House" brand cookie dough preparation room, dry ingredients are placed inside hoppers. The dry ingredients are gravity fed to blending mixers through gate valves that are installed on the hoppers. As a result of this investigation, the firm disassembled all gate valves from all hoppers on production lines 8, 10, 11, and 12. The gate valves appear to have food contact surfaces that are not easily cleanable as evidenced by rough, pitted and discolored cast metal alloy.


Lack of appropriate design to enable manufacturing systems to be maintained in an appropriate sanitary condition. Specifically, as "Toll House" brand cookie dough was mixed on 6-18-09, ice build-up surrounded pipes that transport a processing aid to mixers on production lines 8, 10, 11, and 12. On line 8, condensate from the ice dripped onto a metal rake that personnel then used to scrape cookie dough from the mixer into a dough trough for transport to the filling line.

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  • Art Davis

    “Here are the 2, yes, 2 Observations.”
    Is this meant to suggest that there must be more “observations” that could have been made thus implying either incompetence on the part of the inspectors or worse, colusion between Nestle and the FDA to limit reporting on the 483? Is there no possibility that contaminated ingredients were processed through a pristine facility?
    Perhaps reporting it as “Only two observations were noted on the 483 thus casting additional suspicion on the possibility of ingredient contamination suggesting a need for an enhanced detection program”. This would in no way mitigate Nestle’s responsibility but would more clearly state the case and reduce the authors appearence of bias.

  • John Munsell

    So, the Danville plant had unsanitary conditions, and equipment design did not allow for thorough cleaning and sanitizing. So what? Who cares? If FDA will be required to mandate HACCP protocol at all food plants under its jurisdiction, we need to realize that HACCP liberates food plants to police themselves (such as the Danville plant has been doing), HACCP prevents government agencies from policing food plants (this describes FDA’s historical “oversight” at all food plants, including Nestle’s plant in Danville), and HACCP requires government agencies (FDA & USDA) to disband their earlier command and control authority. We are beginning to see that FDA DOES currently have command and control authority at the Danville plant, which will result in meaningful changes about to occur at the plant. Well, under HACCP, FDA must willingly acquiesce its command and control authority over to the industry. Huh? Sounds crazy, doesn’t it! We could call such a scenario “science fiction”. Well, HACCP is based in science fiction, or political science, or both……..but is certainly divorced from true science. Please know that if Congress perceives that mandatory HACCP at all FDA inspected establishments is even a partial solution to these recurring outbreaks, Congress (and consumers) will be in for a shocking surprise in future years. If our primary focus is safe food and public health, both FDA and USDA must be required to implement a “Hands On” role in all food plants, must police the food industry, and not allow food plants to police themselves. Upton Sinclair’s “The Jungle” revealed (over 100 years ago)the inherent danger in allowing humans to produce food in the absence of any meaningful government oversight. Less than 100 years after Sinclair’s book, and the passage of the Federal Meat Inspection Act, USDA unilaterally relinquished its authority over to the meat industry, gleefully entered into its semi-retirment non-involvement status, and we are currently suffering from the inevitable consequences associated with humans self-regulating themselves. Merely re-energizing FDA and USDA to aggressively monitor production lines at all plants with no artificial HACCP restrictions is not the complete answer. We must couple this with agency bureaucrats who abjectly reject semi-retirement, and proactively enact regulations and policies which force the agencies to embrace a “Hands On” role again. Pathogens are NOT our primary enemy here! Public health has two primary adversaries: (1) The HACCP Hoax, and (2) Government officials who (a) enjoy semi-retirement while still at work, and (b) fear confrontations with powerful industry interests. John Munsell

  • Art – I just meant there were 2, did not mean to suggest that there were more or less. It is a bit odd, however, that the released report is 1, yes, 1 page long.

  • Marymary

    Does the FDA have no authority to inspect plans and equipment before operations begin? (Now that I think about it, I don’t think FDA requires pre-operational inspections. Does anyone know for certain?) One would hope that these design and workmanship issues would have been caught before the Nestle plant began production.
    @ Mr. Munsell: Another food safety blog stated that FDA was not permitted to review Nestle’s HACCP plan. I don’t understand the point of having a HACCP plan if the regulatory authorities are not allowed to read it and check for “critical control points” that the food manufacturer may have overlooked, minimized, or addressed insufficiently.

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