What Happens in a FDA Inspection Following Reports of Sick Pets?

We filed a Freedom of Information Act (FOIA) request with FDA for the consumer complaints (adverse event reports) the agency received linked to pet foods. It took the FDA four years to provide the information (federal law requires government agencies to provide FOIA requested documents within 20 working days).

From the FDA provided FOIA request, Blue Buffalo Pet Food was reported to the FDA 84 times within nine months (6/1/20 – 3/3/21); consumers reporting sick, hospitalized, and pet deaths linked to Blue Buffalo. Click Here to view those adverse event reports.

Based on these adverse event reports, we filed another FOIA request with FDA to learn if the agency investigated these 84 adverse event reports received – if FDA tested any Blue Buffalo pet foods and if FDA inspected the Blue Buffalo manufacturing facility. We waited 9 months for the FDA to provide this requested information.

The recently provided FOIA request did not provide any lab results of testing of Blue Buffalo pet foods. The FDA did NOT test any Blue Buffalo pet foods even though the agency received 84 reports of sick, hospitalized, and pet death reports within 9 months – all reported as linked to Blue Buffalo pet foods.

The FDA did perform an inspection of the Blue Buffalo pet food manufacturing facility, however the inspection was classified as a standard inspection; “CGMP/PC Surveillance inspection“. The FDA website tells us this classification of inspection is: “Surveillance inspections are conducted to monitor the manufacturing process and the quality of FDA regulated products on the market. The agency uses the inspection to evaluate whether a manufacturer is complying with quality manufacturing practices.”

IF the agency was inspecting a pet food plant based on reports of sick, hospitalized, and dead pets – the inspection would be classified as a “for-cause inspection“. “For-cause inspections are triggered when the agency has reason to believe that a facility has quality problems, to follow up on complaints or to evaluate corrections that have been made to address previous violations.”

Thus, this Blue Buffalo inspection was not performed due to the 84 consumer complaints reporting sick, hospitalized and pet deaths over the previous nine months. This inspection was a standard pet food inspection, similar to what would be performed at any pet food manufacturer. An inspection to ‘evaluate’ Blue Buffalo, to assure the manufacturer ‘is complying with quality manufacturing practices.’

So…what is involved in a FDA inspection to evaluate a pet food manufacturer, to determine if the manufacturer is complying with required manufacturing practices? Not much.

First, the FDA did not perform the inspection. Instead, they sent the Missouri Department of Agriculture to perform the inspection on behalf of FDA.

The inspection took place over three days. Two of the three day inspection were performed “virtually“. The virtual inspection “included a complete review of the food safety plan, training records, hazard analysis“.

Note the inspection report stated regulatory ‘reviewed’ Blue Buffalo’s food safety plan, reviewed training records, and reviewed the pet food manufacturer’s hazard analysis. Emphasis on ‘reviewed’ – nothing appears to have been validated.

Statements from the inspection report confirm lack of validation; (bold added) “Firm’s personnel appear to be qualified to perform their assigned duties.” There was no evidence the inspection personnel actually spoke with employees to confirm personnel are qualified.

Regarding employee training, the inspection report stated: (bold added) “the facility and individual assigned duties seems to have been implemented“.

Per the inspection report, the virtual portion of the inspection was little more than regulatory asking questions, and accepting the pet food manufacturer’s responses as factual.

Day three of the inspection was at the pet food manufacturing plant, representatives of Missouri Department of Agriculture performed a “walk through, inspection of further records, grounds and close out was conducted.”

This walk through involved (bold added)…

“Plant in general was kept clean and in good repair.”

“All ingredient and finished product storage is adequately identified.”

“Pest service by (redacted) appears to be adequate. Records of visits and treatment by the contractor were available for viewing.“

The inspection report does not indicate inspectors actually viewed the pesticide records or performed any testing for pesticide residues within the plant.

Were samples of pet food collected for testing? No.

Were samples of raw ingredients collected for testing? No.

Did the Missouri Department of Agriculture discuss the 84 reports of sick pets FDA received over the previous nine months? Only three of the 84 reports were discussed.

The inspectors discussed only “13 complaints” with Blue Buffalo. Five were from 2016, two from 2017, three from 2019, three from 2020. Blue Buffalo told the inspectors “a thorough investigation would have been completed.”

And that was it. The regulatory authorities accepted as factual that this pet food manufacturer performed a thorough investigation regarding consumer complaints. Regulatory did not ask for any evidence of an investigation, regulatory did not request or view any laboratory testing results of pet foods involved in the consumer complaints.

End of inspection.

Click Here to read the full inspection report.

So many concerns…

This was certainly not an inspection, it was a conversation.

Because pet’s lives are at stake, inspections should always include validation of all claims made by a manufacturer. Validation should include testing of raw ingredients and finished pet food for all types of contaminants including pesticides used at the facility. Validation should include discussions with manufacturing employees in confidential settings (not with management only) to determine if claims of proper training are actually implemented.

If a pet food manufacturer claims “a thorough investigation” was performed as follow up to a consumer complaint received, regulatory should closely examine what that investigation entailed.

Regulatory authorities need to hire skilled private investigators to train their inspectors. Regulatory needs to learn how to properly validate claims made by pet food.

Question and answer inspections are not inspections, they are conversations.

Pet owners deserve a lot better than what we are getting from our regulatory authorities.

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
TruthaboutPetFood.com
Association for Truth in Pet Food

Become a member of our pet food consumer Association. Association for Truth in Pet Food is a a stakeholder organization representing the voice of pet food consumers at AAFCO and with FDA. Your membership helps representatives attend meetings and voice consumer concerns with regulatory authorities. Click Here to learn more.

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