Tag: consent decree

Abbott’s walk of shame

As reported yesterday, Abbott Nutrition has entered into a Consent Decree of Permanent Injunction that spells out the conditions under which the company will be permitted to recommence and continue powdered infant formula production at its Sturgis, Michigan, plant.

Despite the company’s protestations of innocence regarding the outbreak of four cases of Cronobacter sakazakii illnesses–including two deaths–in infants who consumed Abbott’s products, the formal Complaint filed by the US Justice Department sets out very clearly the extent of Abbott’s culpability.

The Complaint

After summarizing the relevant statutes, regulations and rules, the Complaint lists the following supporting evidence, found during the inspections carried out by US Food and Drug Administration (FDA) investigators in September 2021 and January-February 2022.

  • FDA lab analysis found C. sakazakii on several surfaces in the production area, including the cover of a hopper that feeds scoops directly into infant formula containers. The sample was collected at the time a batch of formula was being packaged, and the scoops come into direct contact with product.
  • Abbott’s own environmental samples confirmed the presence of Cronobacter spp. on surfaces in the powdered infant formula production area between September 25, 2019, and February 20, 2022. The company did not perform the necessary test to determine whether or not the bacteria were Cronobacter sakazakii.
  • On January 31, 2022, FDA investigators noted the presence of pooled water on several levels of a multi-story spray dryer tower while the spray dryer was being used to produce a batch of powdered infant formula.
  • Abbott’s own records documented a total of 310 “water events” (leaks and condensation) between January 1, 2020, and February 1, 2022, in dry-production areas for powdered infant formula (e.g. during spray-drying and/or container-filling operations). Several of those leaks are described in the company’s records as necessitating repairs to a roof.
  • Abbott had never validated the dry-out step for their spray dryers to ensure that the interiors of the dryers are completely dry following cleaning.
  • Abbott’s own records documented a history of internal deterioration of the spray dryers dating back to September 2018, including (but not limited to) pits and cracks inside the dryers’ main chambers.
  • Plant personnel working in the infant formula production area did not always wear necessary protective apparel.
  • The company failed to conduct an adequate investigation into the validity of a complaint that showed a possible health hazard existed, and failed to test any retained samples of the suspect production lot for microbiological contamination.
  • At the completion of the September 2021 inspection, the FDA issued an FDA-483 form, listing several deficiencies. Although Abbott promised to take corrective action, the company did not implement sustained corrections or demonstrate ongoing compliance with statutory requirements.

On behalf of the FDA, the US Department of Justice has petitioned the Court to issue a permanent injunction requiring Abbott to “… cease manufacturing, processing, preparing, packing, labeling, holding, and/or distributing any article of food unless and until Defendants bring their manufacturing, processing, preparing, packing, labeling, holding, and distribution operations into compliance with the Act and its implementing regulations to the satisfaction of FDA.”

The request also includes authorization for FDA to inspect the company’s “… place(s) of business and all records relating to the receipt, manufacture, processing, preparing, packing, labeling, holding, and distribution of any article of food to ensure continuing compliance with the terms of the injunction, and that Defendants bear the costs of such inspections, including testing and sampling …” and to award costs to the government, including the cost of the investigation to date.

A short leash

The conditions stipulated in the Consent Decree under which Abbott Nutrition will be allowed to resume and maintain production will keep the company on a very short leash.

Abbott will be required to retain an independent expert or experts to evaluate all of the facilities and processes at the Sturgis, Michigan, location, and conduct an inspection to determine what will be necessary to bring the operation into compliance with FDA regulations. The company will be required to notify FDA of the identity and qualifications of the expert within two days after retaining him or her.

Abbott will need to verify the dry-out procedures and validate its method of testing for moisture in production equipment and processing environments.

A pre-production cleaning, sanitizing and dry-out followed by environmental testing for pathogens will be required.

Before starting production, Abbott will be required to provide FDA with a report from the expert that documents completion of all of the verification and validation activities and the pre-production review.

Once production has started, a qualified individual within Abbott’s quality unit will be required to review the batch record, product test results and environmental monitoring for every production lot prior to distribution of the lot. The responsible individual must certify in writing to FDA that each lot meets all specifications.

The consent decree also specifies the testing that must be conducted, and that production be halted and FDA be notified immediately in the event that any in-process or finished product test detects Cronobacter and/or Salmonella. Production will only resume after Abbott receives written permission from FDA.

Abbott must maintain a record of all sales and distribution of its products and make those records available to FDA immediately upon request.

Additional details include specifics as to the required environmental monitoring, training of personnel, preparation and submission to FDA of a plan for building and/or equipment repair, hiring of an auditor to conduct audit inspections of the production facility, methods and processes.

Under the provisions of the decree, in the event the FDA determines that Abbott has not lived up to its agreement, the agency has the authority to order the company to cease manufacturing, and to take whatever other corrective actions the agency deems necessary for protection of public health.

The foregoing is just a sample of the details contained in the 33-page Consent Decree and the 21-page Complaint. Nor is this the end of the story.

In his blog post this morning, Bill Marler warns that criminal sanctions may be in the offing.

Let’s hope the FDA and the US Department of Justice don’t consider Abbott Nutrition to be “too big to nail.”

Learn more about Cronobacter sakazakii and other foodborne disease outbreaks in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.

TAINTED formats 3
“Reads like a true crime novel” – Food Safety News
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Bravo Packing enjoined from producing raw pet food

Company and the US Food and Drug Administration enter into consent decree

A federal judge has entered a consent decree of permanent injuction against Bravo Packing, Inc., a manufacturer and distributor of raw pet food based in Carney’s Point, New Jersey.

(Bravo Packing is not related in any way to Bravo LLC / Bravo Pet Foods, located in Manchester, Connecticut)

The consent decree requires that Bravo “stop selling, manufacturing and distributing raw pet food and come into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).”

The backstory

On September 12, 2018, Bravo Packing announced a voluntary recall of Performance Dog frozen, raw pet food (manufacturing date code 071418) after the FDA found Salmonella in a sample of the product during an inspection of the manufacturing facility.

In addition to the Salmonella-positive sample, FDA Investigator Michael Rosner also documented several issues of concern, including:

  • Some condensate drip and ice buildup was observed on several boxes of finished dog food product in one of the firm’s freezers. 
  • The air curtains entering the dog food processing room were observed to be soiled and in disrepair. 
  • The firm was using a santiizer product at an incorrect dilution level, which reduced the sanitizer’s effectiveness.
  • Some of the claims on the firm’s website were potentially misleading.

By the time the FDA returned to Bravo’s manufacturing facility in July 2019, the situation had deteriorated. This time, the FDA labs found Salmonella and Listeria monocytogenes in samples collected during an investigation that lasted from July 22nd to August 6th.

According to the Inspection Observations report (FDA Form 483), issued by Investigators Teigan Mule and Kyle Coville,

  • after cleaning had been completed, the elbow portion of the feeder pipe from the mixer still had a buildup of dried, dark, crusty meat-like material
  • a film residue remaining on the sides of a mixer exit chute after cleaning
  • greasy buildup of animal fat remaining at the output of a grinder after cleaning
  • black residue on the inside surface of buckets used to hold cut meat
  • condensate drip and ice buildup on boxes of finished raw dog food products in a freezer
  • cardboard boxes used to pack finished product observed to have bird droppings on the tops and sides
  • apparent mammalian (rodent?) droppings adjacent to stored, palletized boxes
  • inadequate training of employees on how to clean and degrease processing equipment after processing.

Although Bravo agreed to recall the contaminated Performance Dog Food product, the company never provided the FDA with the usual draft customer notification letter, distribution list, or draft press release.

In the absence of documentation from the company, the FDA issued its own Consumer Advisory on September 26, 2019, cautioning pet owners “not to feed their pets any Performance Dog frozen raw pet food.”

The FDA followed up its actions with a formal Warning Letter, issued on March 16, 2020. The letter reiterated and expanded upon the observations contained in the inspection report and requested a written response from the company within fifteen working days of receipt.

Downward slide accelerates

On March 3, 2021, Bravo issued yet another recall notice after Salmonella and Listeria monocytogenes were found once again in the company’s products.

The recall was expanded on March 16th to include all pet food and bones in all package sizes.

When the FDA returned to inspect Bravo’s production plant in May 2021, Investigators Kyle Covill and Sean Duke found a situation that had deteriorated further.

  • a shovel used to push meat into the grinder was covered with residual dried, black meat-like material from the handle down to the shaft and all the way to the end of the blade
  • a meat hook covered with cobwebs and other extraneous material was used to move deboned meat from raw ingredient barrels into the grinder during production
  • the grinder contained heavy rust on the inside walls, basins and screw augur
  • a piece of meat from a prior production run was left in the exit portion of the mixer, which also contained a pooled black liquid and white fat-like deposits, and the mixer was subsequently used during production without any further cleaning
  • one of the owners was seen spitting chewing tobacco on the floor of the deboning room
  • two cats were observed urinating on the outside of a raw ingredient barrel that was subsequently used (without undergoing cleaning and sanitizing) to produce Performance Dog ready-to-eat raw dog food
  • the floors in multiple rooms of the production plant, including the processing room, had large cracks, holes and depressions, which contained pooled blood and water
  • uncovered barrels of deboned meat were stored directly beneath a metal beam and brackets covered with flaking rust.

The bottom line

The consent decree prohibits the defendants (including the company’s owner and secretary, Joseph Merola, and its president, Amanda Lloyd) from receiving, preparing, processing, packing, holding, labeling, and/or distributing pet food unless and until the company undertakes and completes a comprehensive list of corrective actions.

The decree also allows the FDA to order a shutdown, recall, or other corrective action in the event of future violations and requires the defendants to pay the costs of inspections performed pursuant to the decree. Failure to abide by the agreement can also lead to civil or criminal penalties.

In commenting on the consent decree, Steven Solomon, DVM, MPH, director of FDA’s Center for Veterinary Medicine, said,

The food we give our pets should be safe for them to eat and safe for people to handle. The FDA has taken this action to protect public health because, despite multiple inspections, notifications of violations, and recalls, this firm continued to operate under insanitary conditions and produce pet food contaminated with harmful bacteria. We will not tolerate firms that put people or animals at risk and will take enforcement actions when needed.”