This past week the CDC declared an outbreak of Cronobacter infections over after the FDA received four complaints of Cronobacter infections in infants beginning on September 20, 2021, through January 11, 2022. Two of the babies died. Parents of all four infants reported having fed their children formula produced by Abbott Nutrition before they became ill. Although five strains of Cronobacter were found in the production plant, none of them was an exact match for the patient samples. The CDC worked with the FDA and state health departments to investigate the outbreak and the plant remains closed while the investigation continues.
A worldwide recall of formula from this plant has caused empty store shelves and desperation from worried parents looking for safe product to feed their children. Infant formula has now become a political football between politicians and caused finger pointing between Abbott and the FDA as to who is causing the formula shortage.
Seven months after FDA received the first report of an infant infected with Cronobacter and nearly five months after the agency initiated its in-depth inspection of Abbott Nutrition’s production facility, several questions to the FDA and public health officials remain:
- In view of what the FDA learned in September 2021 regarding Cronobacter-positive environmental and finished product samples at the Abbott facility, why did it take more than four months for the agency to initiate another inspection after receiving the first of the illness reports?
- Why did the FDA inspectors not respond more forcefully to those Cronobacter-positive results when writing up the list of Inspectional Observations at the completion of their September 2021 inspection?
- As Cronobacter (unlike Salmonella) is not a “reportable” disease in most states, how many additional cases of Cronobacter in infants have gone unreported?
- Why did it take until February 17, 2022, before the public was made aware of the situation?
Congress is set to hopefully get responses from the FDA to these questions in a hearing scheduled for May 25th.
However, let’s not lose sight of the fact that the Cronobacter outbreak, subsequent recall and now formula shortage, would not have occurred but for Abbott failing to produce the formula in a manner that would assure the most vulnerable would not be sickened or die. Looking at the facts surrounding this outbreak illuminate a complete lack of a culture of producing safe food.
Between September 1, 2019, and September 20, 2021, Abbott received seventeen consumer complaints regarding multiple Similac powdered formula products. Fifteen of the complaints related to infants testing positive for Salmonellaafter consuming a Similac product. One complaint cited an infant who was diagnosed with Cronobacter, and one was as the result of an infant death from an unspecified cause. This information is contained in the September 20-24, 2021, Establishment Inspection Report (EIR) from the FDA in response to a Freedom of Information Act request. APPLIED – FOI II – BR Abbott Nutrition- FEI# 1815692 9-2021 EIR., See also, APPLIED – FOI II – Abbott Nutrition FEI# 1815692 EIR 9-24-2019
In response to the Cronobacter complaint, the company reviewed its batch records and its finished product microbiological testing records. The complaint was reviewed by an internal Abbott Nutrition Medical Team. The firm closed the complaint after determining that all batch records were acceptable, that there were no other consumer complaints, and that microbiological testing was negative for Cronobacter. The infant death complaint triggered a batch record review for three lots of Similac Alimentum. After completing the review and determining that no other complaints or medical concerns had been identified for the products, the company closed the complaint.
The fifteen Salmonella complaints involved infants who had been fed one or more batches of Similac Alimentum, Similac ProAdvance, Similac Spit-Up, Similac Total Comfort, Similac Advance, Similac Pro Sensitive or Elecare for Infants. All fifteen of the infants tested positive for Salmonella. Once again, the batch record reviews came back acceptable, and finished product testing results were negative for Salmonella. A finished product sample of one of the implicated batches (Similac Advance lot #472005) was obtained by Abbott Nutrition from the consumer. The sample was subjected to a visual exam, and the container was examined in the packaging lab. The company did not conduct any microbiological tests on this sample.
Abbott Nutrition’s ‘Standard Operating Procedure for Handling Complaints’ specifies that “…any chemical or microbial testing of an unopened customer sample requires the approval of the AN Vice President Quality or delegate.” The EIR does not state whether approval was sought to carry out microbiological tests on the sample.
In addition to the consumer complaints, the EIR also reveals that the company had found Cronobacter in two batches of finished product. The first of these positive results was recorded for Similac Alimentum (Batch 697464), produced on September 25, 2019, just one day after the completion of the FDA’s September 2019 inspection of Abbott’s production facility. The root cause of the contamination was determined to be environmental. The company implemented correction actions and destroyed the contaminated batch. The specific root cause for the second positive result, this time in Similac Spit-Up (Batch 732675), produced on June 22, 2020, was never found, according to the EIR. Several deficiencies were noted during the root cause investigation, corrective actions were implemented, and the batch was destroyed.
In addition to the two instances of Cronobacter in finished products, Abbott also found Cronobacter in five environmental samples between January 2019 and August 2021. There were no Salmonella-positive environmental samples.
In its February 17, 2022, recall notice, Abbott acknowledged “…evidence of Cronobacter sakazakii in the plant in non-product contact areas.” Yet the FDA investigation recovered Cronobacter from at least one swab of what appears to be a contact surface, as described in the 1/31/2022-3/18/2022 Inspectional Observations report (FDA Form 483). Ultimately, the FDA found that Abbott failed to “maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition.”
And there was more; information in a confidential whistle blower document was provided to the FDA in October 2021, by a former employee who worked in the production plant. Redacted Confidential Disclosure re Abbott Laboratories – 10-19-2021_Redacted (1)
The whistle blower document outlines many problems at the Abbott production facility in Sturgis, Michigan, including the following:
- The Falsification of Records – On multiple occasions, and in various ways, records have been knowingly falsified. In most but not all the situations, information of a material nature was not disclosed. This included testing seals on empty cans; signing verifications without adequate knowledge; understating or inaccurately describing events to limit or avoid oversight; issuing certifications of projection pages bereft of pertinent data; shipping packages with fill weights lower than represented on the labels; failing to maintain accurate maintenance records; and prematurely removing holds in the absence of all requisite approvals.
- Releasing Untested Infant Formula – The Sturgis site performed a time code removal after the discovery of microorganisms (“micros”) in a batch of infant formula. The remaining portion of the batch outside the time code removal was released without additional testing. On another occasion product was not re-called from the market even after management became aware of a nonconformity (“NC”).
- The 2019 FDA Audit – Active efforts were undertaken and even celebrated during and after the 2019 FDA audit to keep the auditors from learning of certain events believed to be associated with the discovery of micros in infant formula at the Sturgis site.
- Clean-in-Place Staffing and Practices – The Sturgis site has continued to permit lax practices associated with clean-in-place (“CIP”) procedures. The Sturgis site failed and continues to fail to have staff in place with sufficient training and experience to review CIP charts. Nor are CIP charts regularly reviewed prior to the release of a batch. CIP checklists do not require signatures of those performing the tasks and are not otherwise subject to audit by QS staff.
- Failure to Take Corrective Measures – The Sturgis site has repeatedly failed to undertake reasonable measures to reduce natural or unavoidable defects to the level feasible as mandated by the current Good Manufacturing Practices (“cGMPs”). Deficient testing procedures known to be prone to causing mistakes to have not been corrected. The Sturgis site continues to rely on staff with insufficient training and experience to interact with third-party labs (“TPL”).
- Lack of Traceability – The Sturgis site has ongoing problems associated with the traceability of its products. The automatic labeler frequently failed to work properly and led to significant difficulties in retracing product. QS staff never knew with certainty if an affected pallet was retrieved.
Abbott seems to have forgotten that the product that was being produced was more than a canned commodity but was a life-saving formula to be ingested by the most vulnerable. This is the type of food that requires the highest of standards and mandates the closest of inspections. Yes, babies’ lives depended and depend on it. Abbott will likely face both civil and criminal liability for producing a food product that was tainted and sickened and killed children. Abbott is ultimately responsible for the Cronobacter outbreak and for the contraction of the supply of infant formula.
But additional questions need to be raised to public health officials and FDA regulators.
Public health, specifically, the CDC, needs to reconsider making Cronobacter a nationwide reportable disease, so no illnesses are missing, and outbreaks figured out sooner so the product can be taken off the market in days instead of months.
The FDA leadership needs to be held to account for inadequate inspections and failing to act on the whistle blower warnings. The FDA has essentially been silent on what it failed to do, but more importantly, what it plans to do to prevent the next Cronobacter outbreak and the resulting shock to the supply of infant formula. Parents should not be left with this FDA warning:
Those seeking access [to the formula] should consult with their healthcare provider in considering whether the benefit of consuming such product outweighs the potential risk of bacterial infection in the user’s particular circumstances.
Abbott and the FDA need to do better. Congress needs to put politics aside and ask the questions to find solutions, so this type of event does not happen again.
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