At least 4 sick with 2 babies dead – it’s infant formula for damn sakes!

Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to growing public safety demands.  The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce.  Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health.  The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.

Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:

Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce.  Any person who commits a prohibited act violates the FDCA.  A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by up to ten years in jail and up to $1,000,000 in fines or both – per charge.

A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct.  Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.  Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both – per charge.

Thanks to efoodalert for digging into past inspections of the Sturgis, Michigan, Abbott infant formula manufacturing facility.

Abbott’s infant formula production facility in Sturgis, MI, has undergone twenty-seven FDA inspections since October 2008, according to the FDA’s inspection database. Twenty-four of the twenty-seven inspections resulted in the company’s operations receiving a clean bill of health.

In October 2010, the FDA inspector cited the company for three issues, specifically:

  • Effective measures are not being taken to exclude pests from the processing areas
  • There is no assurance that raw materials which are susceptible to contamination with extraneous materials comply with current FDA standards and defect action levels
  • Failure to manufacture foods under conditions and controls necessary to minimize contamination.

These issues were apparently corrected, as subsequent inspections that same year and for several years did not result in any adverse reports.

The situation changed in September 2019 (Sept. 16-24, 2019), when the FDA inspector cited Abbott for a single issue, stating:

  • You did not test a representative sample of a production aggregate of a powdered infant formula at the final product stage and before distribution to ensure that the production aggregate meets the required microbiological quality standards.

Once again, the company corrected its procedures to the FDA’s satisfaction.

There were no inspections carried out for two full years. Then, in September 2021 (Sept. 20-24, 2021) (unclear if in response to reported illness), the FDA returned. This time, the inspection uncovered several issues:

  • Personnel working directly with infant formula, its raw materials, packaging, or equipment or utensil contact surfaces did not wash hands thoroughly in a hand-washing facility at a suitable temperature after the hands may have become soiled or contaminated.
  • You did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition
  • An instrument you used to measure, regulate, or control a processing parameter was not properly maintained.
  • You did not monitor the temperature in a thermal processing equipment at a frequency as is necessary to maintain temperature control.
  • You did not install a filter capable of retaining particles 0.5 micrometer or smaller when compressed gas is used at a product filling machine.

In its recall notice, Abbott acknowledged having found “evidence of Cronobacter sakazakii in the plant in non-product contact areas, ”but denied having found the bacterium in finished product.

This would appear to be in direct contradiction to the FDA’s revelation that the company had recorded the destruction of product in the past due to the presence of Cronobacter.  Specifically, “a review of the firm’s internal records also indicate environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter.”

The FDA was back in the plant January 31, 2022 through March 18, 2022 as the 2022 Form 483 noted.

Specifically, the FDA environmental samples collected on 2/1/22-2/2/22 confirmed the presence of Cronobacter sakazakki in the packing room on surfaces like the hinge attachment and bolt heads and the clear cover of the scoop hopper. The scoop hopper is utilized to feed scoops, which are placed directly inside infant formula containers and contact product.  Cronobacter sakazakki was found in other samples – structural support piece for the dryer and immediate surrounding floor – duct tape on the wall.

The FDA further noted positive Cronobacter spp. Between September 25, 2019 and February 20, 2022 in both environmental and finished product samples – environmental samples eight times between October 10, 2019 and February 2, 2022 and twenty times between February 6, 2022 and February 20, 2022.  In reviewing NCR’s the FDA found two positive Cronobacter spp. Result in 2019 and 2020.

FDA also noted that standing water was observed repeatedly from September 20, 2021to September 24, 2021, with 310 water events from January, 1, 2020 to February 1, 2022 and personnel working directly with infant formula,… did not wear necessary protective apparel.

Perhaps the most shocking observation by the FDA, was the observation that Abbott did not adequately follow-up on customer complaints Cronobacter sakazakki illnesses and deaths.

Abbott, I would lawyer-up!