I may have missed it, but has anyone got answers to these basic questions? Question 1: Given that the illnesses began in early September 2021, did the fact that Cronobacter sakazakii is only reported in Minnesota hinder the investigation and the delay in announcing the outbreak and recall?
Question 2: Given that the illnesses (of which we are aware) begin on September 6, 2021 until at least December 18, 2021, why was the first recall not announced until February 17, 2022 and the extended recall on 28 February 2022?
Q3: Why were there no FDA inspections at Abbott’s facility in the two years prior to the outbreak and recall? COVID-19?
First, a few basic facts about the outbreak:
To date, there are only confirmed cases in Minnesota, Ohio, and Texas, although there are unconfirmed reports of illness in other states and countries.
One contracted Newport salmonella, four contracted Cronobacter sakazakii with two deaths in Ohio.
These infants consumed formulas including Similac Sensitive, Similac Pro-total Comfort, Similac Advance and Similac PM 60/40. These products have been recalled and should not be used..
Findings to date include several positive results for Cronobacter from environmental samples taken by the FDA at the Abbott Sturgis, Michigan facility. To date, no positive tests for Salmonella have been reported in the product.
A review of Abbott’s internal records also points to Cronobacter sakazakii contamination.
Abbott destroyed the product due to the presence of Cronobacter sakazakii.
Cases in the US occurred between 09/06/2021 and 12/18/2021 – first recall 02/17/22 – extended recall 02/28/22.
The recalled products have been distributed to the following countries other than the US: Australia, Bahrain, Barbados, Bermuda, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong, India, Indonesia, Israel , Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, United Arab Emirates, UK and Vietnam ANI South.
According to the CDC, Cronobacter infections are rare, but they can be fatal in newborns. Infections in infants usually occur in the first days or weeks of life. Two to four cases are reported to the CDC each year, but this figure may not reflect the true number of cases because most hospitals and laboratories are not required to report Cronobacter infections to health departments. While not specifically listed as notifiable in all states, it is notifiable as bacterial meningitis in some states (eg, CA). This is reported in Minnesota.
Thanks to efoodalert for reviewing past and current audits of Abbott’s manufacturing facility in Sturgis, Michigan.
Abbott’s infant formula plant in Sturgis, Michigan, has received twenty-seven FDA inspections since October 2008, according to the FDA inspection database.
Twenty-four of the twenty-seven audits resulted in the company’s performance being deemed satisfactory.
In October 2010, an FDA inspector mentioned the company on three issues, namely:
- No effective measures are taken to eliminate pests from treatment areas
- There is no guarantee that raw materials subject to foreign material contamination will comply with applicable FDA standards and action levels for corrective action.
- Failure to produce food under the conditions and controls necessary to minimize contamination.
These issues appear to have been corrected as subsequent checks in the same year and for several years have not resulted in any negative results.
The situation changed in September 2019 when an FDA inspector referred to Abbott on a single issue, stating:
- You have not tested a representative sample of the production population of powdered infant formula at the end product stage and prior to distribution to ensure that the production population meets the required microbiological quality standards.
Once again, the company adjusted its procedures to the satisfaction of the FDA.
There have been no audits for two full years. Then, in September 2021 (it’s not clear if this was in response to the sickness report), the FDA came back. This time the check revealed several problems:
- Personnel working directly with infant formula, its raw materials, packaging, or contact surfaces of utensils or equipment did not wash their hands thoroughly in a handwashing facility at a suitable temperature after the hands may have become contaminated or contaminated.
- You did not keep a building used to manufacture, process, package, or store infant formula clean and sanitary.
- The instrument you used to measure, adjust, or control a processing parameter has not been properly maintained.
- You did not control the temperature in the heat treatment equipment as often as needed to maintain temperature control.
- You have not installed a filter capable of retaining particles of 0.5 micrometers or less when compressed gas is used in the product filling machine. bmarler
In its recall notice, Abbott acknowledged that it found “evidence of Cronobacter sakazakii in the plant at non-product contact areas” but denied that the bacterium was found in the finished product.
This appears to be in direct conflict with the FDA’s claim that the company has documented product destruction in the past due to the presence of Cronobacter. In particular, “a review of the firm’s internal records also indicates contamination of the environment by Cronobacter sakazakii and destruction of products by the firm due to the presence of Cronobacter.”
I have a few more questions.