This story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission
The Mars Petcare U.S. Inc. low-acid canned pet food production facility in Columbus, OH, was crawling with an infestation of German cockroaches between October 2016 and July 2017. Mars markets wet dog and cat foods in cans, plastic tubs, and laminated pouches under the Pedigree, Cesar, Whiskas, Nutro and IAMS brands.
On Oct. 7, 2016, Mars initiated a recall of 54,255 cases of CESAR Classics Filet Mignon Flavor canned dog food after the complaints about plastic. The recalled products were shipped to 36 states, including to three government facilities.
Ensuing inspections found the company had not completed repairs as promised.
Documents obtained by Food Safety News show that, during a July 2017 inspection of the Columbus facility, investigators from the Food and Drug Administration observed two significant deviations from current Good Manufacturing Practices (cGMP):
- Failure to inspect, segregate, or otherwise handle raw materials and ingredients used in manufacturing under conditions that will protect the animal food against contamination and minimize deterioration; and
- Failure to take effective measures to exclude pests from [the] plant and protect against contamination of animal food by pests.
Roaches and other pests
The infestation was first documented during an Oct. 27, 2016, comprehensive low-acid canned food (LACF) inspection by FDA, according to documents obtained under the Freedom of Information Act.
Although Mars management undertook to address and remedy the infestation in October 2016, FDA investigators observed a live roach in the manufacturing area adjacent to an area where in-process raw materials and ingredients are maintained, and another near the main hand-wash station at the entrance to the manufacturing area during the July 2017 inspection.
According to the company’s Employee Pest Sighting Log, there were 99 instances of pest activity observed during a 72-day period from Nov. 10, 2016, to July 14, 2017, including one instance described as “millions of roaches.”
Employees also reported birds, spider webs, beetles, multiple flies, maggots and larvae on several occasions.
Mars contracts with a pest control operator (PCO) for routine rodent and insect control.
During their review of the PCO’s reports, FDA investigators found references to photographic evidence of pest activity, disrepair of dock doors, general disrepair of the building — including areas of ingress and egress — excessive spills of raw materials and damaged cans “covered” in flies. The photographs had not been retained by the company.
Several of the PCO observations regarding necessary repairs were repeated in multiple consecutive reports. For example, damage to a dock door was first reported on or about Sept. 26, 2016. The report was repeated after each visit until the door was finally repaired on or about Nov. 3, 2016.
Foreign objects – pieces of plastic
In addition to ongoing pest problems, Mars logged repeated violations related to the pieces of hard plastic that spurred the Oct. 7, 2016, recall.
During a March 31, 2017, recall follow-up inspection, Mars informed FDA that the firm had fully implemented corrective actions/preventative actions (CAPAs), including changing all food-contact white plastic material to a blue plastic material, enabling the presence of white plastic foreign objects to be detected more easily.
Despite this assurance, FDA inspectors were told on July 11, 2017, that only the “majority” of the belts and plastic wear plates on critical equipment had been changed out by that date.
As of the July 2017 inspection, Mars acknowledged that it was still receiving complaints from customers about foreign objects in its finished products.
FDA has received two new consumer complaints for plastic foreign objects in Mars canned, tubbed or pouched products since the inspection, according to an agency spokesperson. One of these was for an elastic-type object and the other was for two small, hard plastic pieces. The consumer did not provide a product lot number in the second case, and it is unclear whether the two complaints concerned product manufactured in the Columbus facility.
Refusals and obstruction
The Establishment Inspection Report (EIR) documents a lack of cooperation on the part of Mars management during the July 2017 inspection.
FDA investigators reported Mars officials refusing to cooperate on three points three during the course of the inspection, including:
- Refusal to permit photography
- Refusal to permit the review of consumer complaints
- Refusal to provide photocopies of consumer complaints, manufacturing, shipping and pest control records.
In addition to the outright refusals reported in the EIR, investigators encountered delays in the production of requested documents and information, and denial of complete access to all areas of the facility.
When faced with a refusal, FDA investigators are expected to call attention to the relevant section of the Food, Drug and Cosmetic Act or the Public Health Service Act, and then to complete the inspection, according to Chapter 5 of the FDA Investigations Operations Manual (2018).
The company’s lack of cooperation resulted in a delay in the completion of the inspection, which was begun on July 11, 2017, but was not completed for more than two weeks, on July 26.
According to an FDA spokesperson, the Office of Regulatory Affairs issued an Untitled Letter to Mars subsequent to the July 2017 inspection. An Untitled Letter is used “…for violations that may not meet the threshold of regulatory significance for a warning letter and request correction of the violations.”
The investigation triggered by the recall is now closed.
