Question 2: With illnesses (which we know about) occurring from September 6, 2021 to at least December 18, 2021, why wasn’t the first recall announced until February 17, 2022 and the extended recall on February 28, 2022?
Question 3: Why were no FDA inspections conducted at the Abbott facility for two years prior to the outbreak and recall? Covid-19?
First, some basic facts about the outbreak:
So far, there are confirmed diseases in Minnesota, Ohio and Texas only, although there have been unconfirmed reports of diseases in other states and countries.
One Salmonella Newport patient, four Chronobacter sakazaki patients with two deaths in Ohio.
These children consumed a formula that included Similac Sensitive, Similac Pro-total Comfort, Similac Advance, and Similac PM 60/40. These products have been recalled and should not be used.
The results so far include several positive results for Chronobacter bacteria from environmental samples taken by the Food and Drug Administration at the Abbott Sturgis, Michigan facility. So far, no positive tests for salmonella have been reported in the product.
A review of Abbott’s internal records also indicates environmental contamination with Cronobacter sakazakii.
Abbott destroyed the product due to the presence of Cronobacter sakazakii bacteria.
United States diseases occurred between 9/6/2021 – 12/18/2021 – 1st recall 2/17/22 – extended recall 2/28/22.
The recalled products were distributed to the following countries in addition to the United States: Australia, Bahrain, Barbados, Bermuda, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong, India, Indonesia and Israel Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam ANI South.
according to Center for Disease ControlCronobacter infection is rare, but it can be fatal in newborns. Infection in infants usually occurs in the first days or weeks of life. About two to four cases are reported to the CDC each year, but this number may not reflect the true number of illnesses because most hospitals and laboratories are under no obligation to report Chronobacter infections to health departments. Although not specifically listed as having to be reported in all states, in some states it is reported under bacterial meningitis (eg, CA). It can be reported at Minnesota.
thanks for the efoodalert To explore past and current inspections of the Sturgis, MI, Abbott manufacturing facility.
Abbott’s infant formula production facility in Sturgis, Michigan, has undergone twenty-seven inspections by the Food and Drug Administration since October 2008, according to the FDA inspection database.
Twenty-four of the twenty-seven inspections resulted in the company’s operations receiving a clean bill of health.
In October 2010, an FDA inspector cited the company for three issues, specifically:
- No effective measures are taken to exclude pests from processing areas
- There is no guarantee that raw materials subject to contamination with extraneous materials comply with current FDA standards and defect action levels.
- Not processing food under the conditions and controls necessary to reduce contamination.
It appears that these issues have been corrected, as subsequent inspections in the same year and for several years have not yielded any negative reports.
The situation changed in September 2019, when an FDA inspector cited Abbott in one case, saying:
- A representative sample of total production of powdered infant formula at the final product stage and prior to distribution has not been tested to ensure that the total production meets the required microbiological quality standards.
Once again, the company corrected its procedures to the satisfaction of the Food and Drug Administration.
No inspections were conducted for two whole years. Then, in September 2021 (it’s unclear if it was in response to the reported illness), the Food and Drug Administration returned. The inspection this time revealed several issues:
- Personnel working directly with infant formula, raw materials, packaging, equipment, or surfaces in contact with utensils have not thoroughly washed their hands in a handwashing facility at an appropriate temperature after hands become contaminated or contaminated.
- You have not maintained a building used to manufacture, process, fill or keep infant formula in a clean and sanitary condition
- The instrument you used to measure, regulate or control the processing parameter has not been properly maintained.
- You do not monitor the temperature in the heat treater with such frequency as is necessary to maintain temperature control.
- Do not install a filter capable of holding particles 0.5 µm or smaller when using compressed gas in the product filler.
In the summons notice, Abbott He acknowledged finding “evidence of Cronobacter sakazakii in the plant in non-productive contact areas”, but denied finding the bacteria in the final product.
This may seem in direct contrast to The revelation of the FDA The company has reported product spoilage in the past due to the presence of Chronobacter bacteria. Specifically, “A review of the company’s internal records also indicates environmental contamination with Cronobacter sakazakii and the company’s destruction of the product due to the presence of Cronobacter.”
I still have some questions.