FDA inspections uncover food safety issues at multiple Purina plants

In 2023, the US Food and Drug Administration (FDA) inspected three Nestlé Purina production facilities. All three manufacturing plants produce Purina ProPlan pet foods in addition to other brands owned by Nestlé Purina.

While the inspections predate the current concerns raised by pet owners regarding Purina ProPlan, the reports shed some light on the manufacturing and quality assurance practices at these locations.

This facility manufactures extruded dried kibble and extruded treats under several brand names, including: Pro Plan®, Nestlé Purina ONE Beyond®, Nestlé Purina Veterinary Diets®, and Beggin®.

On February 8, 2023, Nestlé Purina announced a recall of Purina Pro Plan Veterinary Diets EL Elemental dry dog food due to “potentially elevated levels of Vitamin D.” The recall covered seven production codes.

Approximately one month later, on March 10, 2023, the company expanded its recall to include two additional production codes.

The recalled products were manufactured in Clinton, Iowa, using a vitamin pre-mix supplied by ADM Nutrition.

ADM is a self-described “… global leader in human and animal nutrition…” with net sales in 2020 of $64 billion.

On February 14, 2023, less than one week after the initial Purina recall announcement, the FDA began a three-day long inspection of the Clinton manufacturing facility.

The investigators reviewed the company’s Hazard Analysis for the recalled product, noting that it identified nutrient (including vitamin D) toxicity and deficiency as hazards likely to occur.

Nestlé chose to apply what is referred to in the inspection report as a “supply chain preventive control” for this hazard. The control consisted of obtaining the vitamin pre-mix from a third-party supplier (ADM Nutrition).

Nestlé did not test either the pre-mix or the finished pet food to ensure that the Vitamin D level was correct.

The conclusion of the FDA investigation team was clear and unequivocal.

The failure to test the inbound pre-mix, the failure to test the finished Purina Pro Plan Veterinary Diets Elemental (PPVD EL) prescription dry dog food, and/or the lack of any other appropriate monitoring or verification steps resulted in your release of the product to the public. These vitamin D levels were up to 77 times (103 IUs/gram versus 1.33 IUs/gram) your expected levels. The consumption of these released lots of product resulted in animals needing veterinary care, and subsequently resulting in your recall of the product.

FDA Establishment Inspection Report (FEI #1924965) for Nestle Purina Pet Care Co., Clinton, IA (February 14-17, 2023)

Although the inspection result ultimately was categorized as “Voluntary Action Indicated,” no formal Inspectional Observations report (Form 483) was issued.

On March 13, 2023, the FDA began a four-day inspection of the ADM Nutrition plant that had supplied the pre-mix to Nestlé.

The investigation team found that ADM’s “prerequisite program” had been inadequate to prevent a wrong ingredient from being added to the pre-mix that was supplied to Nestlé. ADM did not test the pre-mix before supplying it to the Clinton plant.

According to a Warning Letter issued on October 23, 2023, ADM had no preventive controls in place to mitigate the risk of error.

Once again, the FDA’s conclusions were unequivocal.

[T]he findings of elevated levels of vitamin D in several lots of your AA Diet preblend indicate your prerequisite programs were insufficient or you failed to implement them adequately to ensure the inclusion of vitamin D did not result in a nutrient toxicity.

FDA Warning Letter (CMS Case #657846) issued October 23, 2023

This location manufactures Alpo®, Nestlé Purina ONE®, Pro Plan®, Friskies®, and Nestlé Purina Veterinary Diets® canned dog and cat foods.

On December 2, 2022, the company announced a recall of a “limited amount of Purina Pro Plan Veterinary Diets EN Gastroenteric Low Fat” due to what it described as a labeling error.

On June 27, 2023, the FDA began a three-day inspection of the facility as a follow-up to the recall and to seventeen consumer complaints received by the agency between 2018 and 2023 about foods manufactured at the Crete location.

During the inspection, the FDA investigator learned that the mislabeling of cans was due to a can conveyor motor malfunction. The stoppage of the conveyor line caused sealed cans to accumulate, forcing a diverter gate to open and allowing the comingling of two different products—a cat food and a dog food—prior to the retort (pressure cooking step).

Although the recall notice cited a simple mislabeling, the risk was more serious. According to the inspection report, the “…inadvertent diversion of the product prior to retorting led to the product receiving the incorrect thermal process.”

The consumer complaints included presence of foreign objects, pet illness or injury, and off odor/appearance.

The inspection report notes that the plant did not identify foreign material as a hazard requiring a preventive control, but relied on magnets to detect and remove metal objects from the in-process pet foods.

The investigators also observed problems with the plant’s control of residual chlorine in cooling water.

When cans of food leave the retort, they pass immediately into a water-filled cooling canal. The water is chlorinated to prevent growth of microorganisms, including both bacteria and yeasts.

As the cans cool, a partial vacuum forms inside, which can result in a small amount of cooling water being sucked in.

If the water is not sufficiently chlorinated, live bacteria and yeasts can be carried into the cans. These might be spoilage microbes, or even pathogens.

According to the inspection report, although the cooling water was monitored regularly for chlorine, corrective action was not always taken when the chlorine level fell below the target specified in the company’s food safety plan.

Although these observatons were discussed with management at the close of the inspection, no formal Inspectional Observations report (Form 483) was issued, and the inspection result was classified as “No Action Indicated.”

This location produces extruded dry pet food for dogs, puppies, cats, and kittens under nine brand names: Friskies, Cat Chow, Kit N Kaboodle, Kitten Chow, ONE, Alpo, Beneful, Dog Chow, and Pro Plan.

On April 11, 2023, the FDA conducted a routine inspection of the Edmond location, to review the firms Food Safety practices and discuss a total of six consumer complaints received since the previous inspection in 2019.

Unlike the situation in Clinton and Crete, the inspector found no deviations or deficiencies in the Edmond operations.

The plant uses a supply chain control program that includes pre-requisite approval of all suppliers by the Nestlé Purina corporate office. The plant also submits samples periodically to the corporate lab for nutritional analysis.

The Food Safety Plan uses a single Critical Control Point (“kill step”) for all of its products: extrusion time/temperature. Finished product is tested for Salmonella before being released for distribution.

The inspection was classified as “No Action Indicated.”

Two other locations—Denver and Flagstaff—also manufacture Purina Pro Plan pet foods.

The Flagstaff production plant was last inspected in 2019. It produces dry, extruded pet food under the following brands: Dog Chow®, Beneful®, Nestlé Purina ONE®, Alpo®, and Pro Plan®.

Although no Form 483 was issued at the completion of the 2019 inspection, four deficiences were discussed with management:

  • Inadequate control to minimize the risk of metal foreign object contamination
  • Written food safety plan was not revised to reflect significant change in activities
  • Large gaps in seals around overhead doors in multiple locations
  • Plastic wrap being used as a seal in an air system.

Two of the four issues were corrected and verified before the close of the inspection, and the inspection was classified “No Action Indicated.”

Denver was last inspected in 2018. The location produces pet food under the following brands: Dog Chow®, Cat Chow®, Kit n Kaboodle®, Alpo®, Beneful®, Nestlé Purina ONE Beyond®, Nestlé Purina ONE®, and Pro Plan®.

The 2018 inspection was classified as “No action indicated.” eFoodAlert has requested, but has not yet received, the Establishment Inspection Report for this inspection.

According to the FDA’s Investigations Operations Manual, a Form 483 should be issued …when in the investigator’s judgement, conditions or practices observed indicate that any food, drug, device, or cosmetic has been adulterated, or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.”

This may (and should) include issues such as elevated mycotoxins, presence of pathogens (such as Salmonella), and toxic levels of Vitamin D in pet foods.

It is also arguable that multiple instances of inadequate control of can cooling water should trigger issuance of a Form 483.

In reading the various Establishment Inspection Reports, it becomes clear that while the corporate office provides some direction, each manufacturing location has at least partial autonomy over its operations and food safety decisions.

The Clinton location made no attempt to test either its pre-mix ingredient or its finished products for Vitamin D levels, relying solely on ADM to provide the specified formulation. In contrast, the Edmond plant submitted periodic samples to the corporate lab for nutritional analysis.

There are multiple references to supply-chain controls, which boil down to relying blindly upon one’s suppliers to provide a product that meets all specifications.

The Clinton experience with faulty pre-mix supplied by ADM is a glaring example of how dangerous this practice can be. A simple, routine test of each batch of pre-mix would have prevented the release of multiple production lots of toxic pet food.

In January 2024, eFoodAlert reported on an alarming number of consumer complaints about pet illnesses and deaths that appeared to be associated with Purina pet foods.

An FDA investigation into these illness reports is ongoing.

If you or your veterinarian believe that your dog or cat has been injured in any way by a commercial pet food or treat, the FDA wants to hear from you. Visit the FDA web page, How to Report a Pet Food Complaint for a detailed explanation of how to file a complaint.


The Establishment Inspection Reports issued by the FDA and referenced in this report were obtained in response to Freedom of Information Act requests.



“A complete and compelling account of the hidden and not-so-hidden ways the food we give our beloved pets can be contaminated.” JoNel Aleccia, Health Reporter, Food & Nutrition, The Associated Press.

“An invaluable resource for busy pet owners” – Food Safety News

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25 thoughts on “FDA inspections uncover food safety issues at multiple Purina plants

  1. Love your updates, Phyllis — and Purina is used here pretty much exclusively — the vitamin D issue was a problem with Evanger’s in the last two years, too. Thanks for keeping our pets safe!

    Liked by 1 person

  2. What I’d like to know is if any of the plants made positive changes as a result of the inspections. The fact that these inspections in 2023 turned up some issues that have the potential to cause more problems has me worried about the safety of all Purina foods.

    Yes I’m aware of the FB group, but I also have 6 cats who were eating Purina Fancy Feast wet food, who suddenly all started vomiting and refusing to eat (nauseous) in the span of less than 12 hours. We switched them all immediately off the Fancy Feast and provided simple nausea meds from the vet (2 needed sub q fluids too) and within 24-48 hours were all normal again. None of the vomit contained hairballs or foreign objects, their poops were all normal. How can 6 cats all suddenly develop the same symptoms, when the only common denominator was their food?

    I have had multiple cats with long term health problems, the slightest change in behavior sets off warning alarms for me to monitor for other symptoms or bring them into the vet. None of these cats were acting abnormal before they started vomiting.

    The vet believed at least one case of the wet food was stored improperly before it was delivered to us. Given Purinas history of recalls, I’ve decided to stop using them and Chewy, who delivered the food to us.

    I’ll feel safer if the FDA comes back with any findings for the most recent string of complaints, but until then I’m not putting the safety and health of my pets at risk given my own experiences alone.

    I’m also still pissed Fancy Feast confirmed they added soy to one of the flavors one of our cats exclusively ate, and she was the sickets of the 6. Cats do NOT need soy. There’s quite a few other ingredients in many cat food brands that just should not be there

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  3. i think it’s about time inspections should be a lot more frequent and intense. 64 billion dollars has greed written all over it. We need accountability and severe penalties for rich companies to shrug off little violations like a nat in your ear. Shut them down if they continue ignoring penalties.

    Liked by 2 people

    1. Unfortunately, Congress never allocates sufficient budget to the FDA to allow more frequent and intensive inspections, either of pet food or human food manufacturing plants. Also, the FDA’s hands are tied when it comes to taking serious enforcement actions, such as shutting down a plant. Most actions require the cooperation of the DoJ, which can choose whether or not to take on a specific case.

      Liked by 1 person

  4. So no new information. Just you reposting old news from 2022 and 2023 for what? The fear mongering needs to stop. You’re group of people are doing more harm than good to animals and their owners.

    Like

  5. My Morkie has been on different commercial dog foods, including Beniful. For 12 years he has suffered major skin itching infections and three seizures IFor three years he’s has been on Apoquel and Cytopoint After nothing helped I stopped all dog food and gave him human grade food Within one month no more itching or seizures. I will NEVER give my dog dogfood again. I think it’s the preservatives and crap they add that is not even required by law, listed on the package. Please help our fur babies

    .

    Liked by 1 person

    1. the people at the plant should be made to eat that dog food that is bad it is so wrong that they do not test all batches you pay enough for dog food it’s a shame that they have to treat our animals like that just for greed

      Like

  6. You do realize that you are helping to fuel the fire over a bs rumor some idiot started to get likes on FB and Tictok. Others joined in with their lies hoping to cash in on likes also further spreading the rumor. They have certainly lost sales and could cause people to lose their jobs, if some haven’t already.

    If you do your research for the actual facts/findings/outcomes about this company you will find they have had less issues than most pet food company’s and far less than from the company’s we get our food from. Also take note on how long they have been around. They majority of their recalls have been voluntary and only a few that were something severe such as Salmonella.

    Im not a fan of all the brands they put out like Beneful, which is crap, but it’s certainly not deadly.

    I just think it’s unfair. And I’m generally so sick of all the lies that are being spread over news and media and how people believe these lies so quickly without even a care.

    We all need to do better and get our morals back.

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    1. Tell you what you eat this garbage they are labeling as Pet Food then tell me how sick you get and you think it’s all a lie maybe then you will start researching how bad this really is Maybe you don’t consider your Furbabies Family i and most other people do we have a right to good safe Healthy nutritoius food for them.with transparency in labeling ingredients so we know what we are giving our family members the big pet food conglomerates are in this business for one thing as much profit as possible for the cheapest product possible they have no compuncuations or caring if they poison your family member

      A friend of mine worked for the FDA so please don’t try to BS me i also was in government service

      AJ Cattan

      Liked by 1 person

      1. yeah the nice thing about being online is you can be or say anything that you want and I believe that is what you’re doing you know nothing you’re just trying to get attention

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    2. there shouldn’t be a few they should be none that gets sick for what they sell for food and if somebody done something wrong they should lose their job

      I did not believe you have a pet that you care about

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    3. My dogs just had all their blood work, yearly tests, shots, etc. They have been eating Purina for years with constant allergies issues. My dog was diagnosed with colitis young. My dogs didn’t want to eat the last few batches of Purina. I had to add a small amount of chicken to get them to eat it. Then my dog started pooping runny slimy stuff. Then bloody. Then the other two soon followed suit. My dog is 12 and never had issues. The others are 4 and 6 with no other issues except allergies and food making them sick. Yes it is the food. If you don’t know what you’re dealing with it talking about then maybe just shut up. It’s so rude to tell people what they are going through is fake when you aren’t living through it fighting for your fur babies lives. Trying everything possible and still they have issues after Purina. Stop trying to get them back to their selves. This company should be sued by everyone involved.

      Liked by 1 person

  7. Had I realized Nestlé had acquired Purina I would have stopped using their products. Until we start enforcing our Anti-Trust Laws we will never again achieve the quality of products I grew up with. Profit over everything is killing us and our pets. When I was in college purina canned catfood smelled and looked different, almost edible, there were visable peas and little bits of carrot in the can. Now it all looks and smells the same, like cardboard and spoiled meat. What are consumers to do?

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      1. hi Phyillis, could you please share your dog recipes? I also cook for my dogs and cats as I worry so much about these issues in pet foods. I just want to make sure I make foods with the right vitamins. I would value your advice. My pets really enjoy homemade food.

        Liked by 1 person

        1. Hello Marie. We feed our dog a fully cooked diet consisting mainly of ground beef, chicken, beef liver, sardine, salmon and quinoa (not everything in every meal!). I sprinkle finely ground eggshell on each meal to ensure she gets an appropriate supply of calcium in her diet. She also gets an occasional “treat” of plain Greek yoghurt, cheese (usually Jarlsberg, as that’s my go-to cheese), and home-baked liver cookies. All of the detailed recipes are in Chapter 13 of TOXIC. Fruits and veggies are also good to include in your dogs’ diets. However, our girl is not fond of them.

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        2. Thank you Phyllis! My dogs enjoy Jarksburg too! I give them a snack of it early evening as I prepare their dinner. Do you use a vitamin supplement in addition to eggshell powder? I sprinkle Taurine powder on the kitties food, and nutritional yeast on the dog’s food. The dogs enjoy fruits and vegetables. I am not sure what else supplement wise I should add. I do give some commercial dog and cat food daily that I think is safe but I wouldn’t mind giving all home cooked if I can make it complete. Despite the worry of what I have not added, I always feel that their canned or bagged stuff has the worst foods in it even if not toxic, I do not feel it is good enough, just like I would not want to eat only processed foods. 

          Liked by 1 person

        3. You’re very welcome. I used a vitamin supplement when our dog was a pup, but she eventually turned up her nose at it and I listened to her opinion. I spent some time working out probable nutrient profiles by using the nutritional information for individual foods that can be found on the USDA site and am reasonably confident that she is getting everything she needs. The taurine powder is probably a good idea for your cats. Given the number and variety of pet food issues that have cropped up over the last decade or two, I’m leery about adding any commercial food to her diet. There are a couple of good books on feeding home-prepared diets that I’ve also used for guidance. One, in particular, offers recipes for a variety of situations, including special diets for chronic health conditions. the title is “Home Prepared Dog and Cat Diets, 2nd edition.” It can be found on Amazon.

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    1. You got to be kidding me my dog died from purina one 4 days after opening a new bag he had no prior complications on Dec 27 it’s not a rumor

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      1. so you got a necropsy stating the food killed your dog? Thats the only way to confirm.

        if your dog died 10 days after opening it, would you blame the food? What about 20? Where is the line drawn?

        I have never blamed the food my animals have eaten as the cause of their death or illness. I bring them to the vet.

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        1. 4 days is pretty suspect. I wouldn’t suspect a food as the cause if symptoms started 10 or more days after a new bag, but the poster specifically said their dog died 4 days after opening the bag. That means symptoms most likely started sooner. I’ve also seen A LOT of pictures online of issues with Purina Dog food. Visually looking off, or finding bugs in the bags. Sure there could be a bunch of reasons for this, could be faked if you want to go that route. But it’s pretty obvious from these inspections the plants aren’t doing the best job of keeping pet food safe

          Also most people cant afford a necropsy, but that’s too short a time to just dismiss people

          Like

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