On Feb. 16 the Food and Drug Administration (FDA) issued a close out letter, officially putting an end to its investigation of a manufacturing plant operated by Evanger’s Dog & Cat Food Co. Inc.
The FDA action followed the transfer of all manufacturing operations from the troubled pet food production operation in Markham, IL, to a plant operated by Nutripack LLC in June 2017. The FDA’s investigation began after a consumer complained that the company’s canned dog food had made her dogs severely ill, killing one of them.
Lab samples taken during an autopsy of the dog and from the can of food it had eaten showed the presence of a significant quantity of pentobarbital, a barbiturate used to euthanize animals. Animal food is considered to be adulterated under federal law if it contains even a trace amount of pentobarbital, according to FDA.
Subsequent tests carried out by FDA confirmed the presence of pentobarbital at varying concentrations in 13 out of 14 Evanger’s dog food samples tested. The barbiturate was present at levels as high as 81 parts per million.
In 1998 and 2000, FDA conducted a pair of surveys to determine whether and to what extent dry dog food contained pentobarbital. The highest concentration they found in any sample was 32 parts per billion.
The amount found in the most heavily contaminated Evanger sample was more than 2,500 times the highest level found in dry dog food during a 2000 FDA survey.
The lethal oral dose of pentobarbital for a dog is about 85 milligrams of the drug per kilogram (2.2 lbs) of body weight. A healthy 10-pound dog would need to consume approximately its own body weight in food in order to receive a lethal dose of pentobarbital, if the food was contaminated at a level of 81 parts per million.
The pentobarbital finding triggered an FDA inspection both of the Evanger and of the Nutripack manufacturing facilities in January-February 2017. As reported in February 2017 by Food Safety News, inspectors documented several violations at both locations.
Both Evanger’s and Nutripack are owned and operated by members of the Sher family.
In October 2017, FDA carried out a “comprehensive, compliance follow-up inspection” at Nutripack, according to information contained in an Establishment Inspection Report (EIR) obtained by Food Safety News under the Freedom of Information Act.
Inspectors found several objectionable conditions, which they discussed with the company’s management at the end of the multi-day investigation. These included:
- No evidence of any heat or temperature distribution studies on any of the retorts used to process the company’s low-acid canned pet food product, and no data to support that the venting schedule used by the company was sufficient to ensure that all air is removed from the retorts prior to processing.
- No accuracy tests performed on the retort temperature-indicating devices. These devices are required to be tested for accuracy at least once a year.
- The plant was not maintained in good repair to prevent the animal food from becoming adulterated. Water was observed to be dripping directly from the ceiling onto various packaged and palletized finished products, on raw ingredients stored in a plastic drum and on empty cans stacked on top of pallets in the warehouse.
- Measures to exclude pests from the plant were ineffective. A live mouse was observed running through the production area while it was in operation and there were “too numerous to count” rodent-like pellets along one wall behind the retorts.
- The grounds around the building were not maintained in a condition that would protect against pests that might penetrate into the facility.
Management made the following corrections during the course of the inspection, and promised to respond to all of the observations in writing within 15 business days:
- Dual check valves were installed on a hand washing sink next to a hand pack line after FDA inspectors noted the lack of proper back-flow prevention devices
- In-process products were labeled during production to monitor traceability
- Documentation was provided regarding planned installation of insulating material above the production area to prevent condensate.
According to the October 2017 EIR, the issues cited by FDA investigators during the two Nutripack inspections “…were observed to be corrected by the firm or [were considered] to pose no imminent public health concerns.”
On the company’s website, the Sher family highlights its efforts to “create an exceptional level of quality control system and production in a new state of the art manufacturing facility in Markham, IL,” and pledges to “work closely and in full cooperation with the FDA.”
Nevertheless, upon the arrival of the FDA investigators at Nutripack on Oct. 11, 2017, Joel Sher, identified as manager/president in the FDA report, shut down production on the “Hand Pack” pet food line. When one of the investigators asked for a reason, Sher replied that he “did not want a write up.”
During the October 2017 inspection, FDA investigators were refused permission to document their observations by photography. Sher permitted investigators to photograph only certain company-provided documents that were not able to be copied using the firm’s printer.
Sher also refused to read, to have read to him, or to sign, a one-page affidavit. The unsigned affidavit was appended to the EIR as an exhibit, but the contents of the document were not revealed in FDA’s response to the Freedom of Information Act request.
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