At least 4 sick and 2 dead babies – that’s formula for God’s sake!
Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in response to increasing demands for public safety. The primary purpose of the act was to protect public health and safety by preventing deleterious, adulterated, or mislabeled items from entering interstate commerce. Under section 402(a)(4) of the act, a food product is deemed “adulterated” if the food was “prepared, packaged, or stored under unsanitary conditions in which it may have been contaminated with rubbish or in which it may have been rendered injurious to health”. A food product is also considered to be “adulterated” if it contains or contains a poisonous or deleterious substance which is likely to render it injurious to health. The 1938 Act and the recently signed Food Safety Modernization Act is now the primary means by which the federal government enforces food safety standards.
Chapter III of the law deals with prohibited acts, subjecting offenders to both civil and criminal liability. The provisions relating to criminal sanctions are clear:
Criminal offenses include adulteration or mislabeling of a food, drug, or device, and placing in interstate commerce of a adulterated or mislabeled food, drug, or device . Anyone who commits a prohibited act violates the FDCA. A person who commits a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by up to ten years in prison and up to $1,000,000 in fine or both – per charge.
A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even knowing or deliberate conduct. On the contrary, a person can be condemned if he held a position of responsibility or authority in a company such that he could have prevented the violation. Convictions under the misdemeanor provisions carry a maximum sentence of one year or a maximum fine of $250,000, or both – per charge.
Thanks to food alert for delving into past inspections of the Abbott infant formula manufacturing plant in Sturgis, Michigan.
According to FDA inspection database. Twenty-four of the twenty-seven inspections resulted in the company’s operations receiving a certificate of good health.
In October 2010, the FDA inspector cited the company for three issues, specifically:
- Effective measures are not taken to exclude pests from processing areas
- There is no assurance that raw materials that may be contaminated with foreign materials will meet current FDA standards and defect action levels.
- Failure to manufacture food under conditions and controls necessary to minimize contamination.
These problems have apparently been corrected, as subsequent inspections in the same year and for several years did not result in any unfavorable reports.
The situation changed in September 2019 (September 16-24, 2019), when the FDA inspector cited Abbott for a single issue, stating:
- You failed to test a representative sample of a powdered infant formula production aggregate at the final product stage and prior to distribution to ensure that the production aggregate meets the required microbiological quality standards.
Once again, the company has corrected its procedures to the satisfaction of the FDA.
No inspections were carried out for two full years. Then, in September 2021 (September 20-24, 2021) (unsure if this is a response to a reported disease), the FDA came back. This time, the inspection revealed several issues:
- Personnel working directly with infant formula, its raw materials, packaging, or equipment or utensil contact surfaces failed to wash their hands thoroughly in a hand-washing facility at an appropriate temperature after hands are soiled or contaminated.
- You failed to maintain a building used in the manufacture, processing, packaging or storage of infant formula in a clean and sanitary condition
- An instrument you have used to measure, regulate or control a process parameter has not been properly maintained.
- You failed to monitor temperature in thermal processing equipment at a frequency necessary to maintain temperature control.
- You have not installed a filter capable of retaining particles of 0.5 microns or less when compressed gas is used in a product filling machine.
In its recall notice, Abbott acknowledged having found “evidence of Cronobacter sakazakii in the factory in areas without product contact, but denied finding the bacteria in the finished product.
This seems to be in direct contradiction to the The FDA revelation that the company had recorded the destruction of product in the past due to the presence of Cronobacter. Specifically, “A review of the company’s internal records also indicates contamination of the environment with Cronobacter sakazakii and the company’s destruction of the product due to the presence of Cronobacter.”
The FDA was back in the factory from January 31, 2022 to March 18, 2022 as 2022 Form 483 Noted.
Specifically, FDA environmental samples collected from 2/1/22 to 2/2/22 confirmed the presence of Cronobacter sakazaki in the packing room on surfaces such as the hinge attachment and bolt heads and the clear shovel hopper cover. The scoop hopper is used to feed scoops, which are placed directly inside infant formula containers and come into contact with the product. Cronobacter sakazaki was found in other samples – structural support piece for dryer and immediate surrounding floor – tape on wall.
The FDA further noted positive results Cronobacter spp. Between September 25, 2019 and February 20, 2022 in 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. The FDA has found two positives Cronobacter spp. Result in 2019 and 2020.
The FDA also noted that standing water was observed repeatedly from September 20, 2021 through September 24, 2021, with 310 water-related events from January 1, 2020 through February 1, 2022 and personnel working directly with infant formula,… was not wearing the necessary protective clothing.
Perhaps the most shocking observation from the FDA is the observation that Abbott has failed to adequately follow up on customer complaints. Cronobacter sakazaki illnesses and deaths.
Abbott, I’ll get a lawyer!