FDA calls some process deviations at Purina plant 'out of control'
Warning letter cites multiple violations at Allentown facility and threatens further action if prompt corrective actions are not made.
The U.S. Food and Drug Administration (FDA) has cited Nestlé Purina for "significant deviations" from low-acid canned food regulations at its Allentown, Pennsylvania, plant.
A warning letter dated Jan. 2 but released publicly last week says Nestlé Purina is responsible to adhere to guidelines regulating the low-acid canned food manufacturing process. These guidelines are critical, the FDA says, because low-acid foods "may be adulterated ... in that they have been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health."
Wendy Vlieks, director of Nestlé Purina PetCare Company's Corporate Public Relations, says the pet food manufacturer is confident there are no food safety issues or risks to pet health with products produced at the Allentown plant.
According to the FDA, the Nestlé Purina plant failed to:
> Process each low-acid canned food in conformity with at least the scheduled process filed with the FDA. This involves differentiating process times, minimum sterilization temperatures, cook times, temperature drops during processing and consistent pouch thickness for packaging.
> Identify, from a processor check or otherwise, deviations from the scheduled process of critical factors, which are "out of control"; the company also failed to record these deviations in a separate log.
> Chlorinate or otherwise sanitize cooling water.
> Establish a system for the traffic control room to prevent unsterilized product from bypassing the sterilization process.
> Install mercury-in-glass thermometers in a location where they can be accurately and easily read.
> Have all processing and productions records signed or initialed by a representative or plant manager.
One item on the FDA’s list of violations reads, "Your firm failed to identify, from a processor check or otherwise, deviations from the scheduled process of critical factors which are out of control and failed to record these deviations in a separate log, as required … "
Vlieks told dvm360, "The statement ‘out of control’ refers to specific regulatory process parameters and not the state of our Allentown factory.” She says that while the items outlined by the FDA do not pose a pet food safety risk, Nestlé Purina is taking the FDA letter seriously.
“The quality of our products is a top priority,” she says. “We have a comprehensive food safety program and dedicated quality assurance staff in each of our North American pet food facilities to ensure the quality of every Purina product.”
The FDA says it previously received a written response from Nestlé Purina regarding these inspection observations, but the agency did not accept it. Appropriate documentation of process deviation was not provided, the FDA says, and the response failed to state plans to discontinue manufacturing until problems were addressed or to provide specifics of a corrective action plan.
"You should take prompt action to correct the violations described in this letter and establish and implement procedures which will prevent them from occurring in the future," the warning letter states. "Failure to take appropriate corrective action may subject your firm and products to further actions, such as emergency permit control, injunction, or seizure."
Vlieks says Nestlé Purina is in the process of clarifying its initial response to FDA, including corrective actions and additional documentation. "We are confident that our response will address the FDA's concerns," she says. "The items called into question are primarily administrative and involve our conservative self-determined processes, which we will be re-evaluating."
At this time, there have been no recalls concerning products made at the Allentown plant.
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