With whistleblower complaint, congresswoman questions why FDA waited to investigate Abbott

·4 min read

Construction work was apparent at the Abbott Nutrition's plant on Centreville Road last week.

Congress is now investigating contamination at the baby formula production facility after infant deaths and infections.

Connecticut Democratic Rep. Rosa DeLauro revealed in a statement Thursday that a whistleblower sent U.S. Food and Drug Administration a 34-page document outlining potential concerns with the Sturgis plant in October.

The congresswoman said in a statement that a former plant employee accused the plant management of hiding information during a 2019 FDA audit. The whistleblower also cited lax cleaning practices, falsifying records and releasing untested infant formula.

DeLauro and other members of Congress now want to know why FDA didn't take action earlier.

Abbott said in a statement after it shut down baby formula production following an inspection by FDA from Jan. 31 to March 18, "We are currently reviewing the U.S. FDA's 483 observations from the inspection of our powder formula manufacturing in our Sturgis, Mich., facility. We're taking this very seriously and are working closely with the FDA to implement corrective actions."

The FDA investigation began after one infant death and two serious infections were reported. FDA added a second death and several more illnesses to the investigation.

FDA said a Cronobacter infection may have contributed to the cause of death for both patients.

Abbott noted that in all four cases, the state, FDA and/or CDC tested samples of the Abbott formula that was used by the child. In all four cases, all unopened containers tested negative.

Formula at the homes of three cases were tested. The one positive was from an open container. It tested positive for two different strains of Cronobacter sakazakii. One strain matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula. Neither strain matched strains found in at the Sturgis pant.

The infected infants consumed four different types of our formula made over the course of nearly a year. The illnesses took place over several months in three different states.

The inspection issued by FDA's Detroit office confirmed some of the allegations. Ten inspectors, including a national office health expert, visited the plant.

Inspectors found, "In the packaging room for filler line the hinge attachment and bolt heads on the top, clear cover of the scoop hopper was swabbed and was positive for Cronobacter sakazaldi. This scoop hopper is utilized to feed scoops, which are placed directly inside infant formula containers. You consider this a high-care area."

The report redacted details regarding location and unit equipment.

Abbott said in its latest statement: "While there are actions we need to take to address the FDA observations, it is important to note that no Cronobacter sakazakii or Salmonella was found in any of our testing of products distributed to consumers. Additionally, the unique genetic makeup of the Cronobacter sakazakii microbes found in non-product areas at the Sturgis facility did not match the Cronobacter sakazakii microbes from the reported cases" related to the deaths or infections.

Abbott noted “After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses.”

The inspection also located in a medium critical area "duct tape on the floor; debris was observed beneath and on top of the duct tape. The area between the duct tape and the wall was swabbed and was positive for Cronobacter sakazakii." Tests were positive.

Investigators observed those in the plant walking between general areas of the plant and into production areas without changing or disinfecting footware.

Abbott knew of the contamination, the report stated.

"Between 9/25/19 and 2/20/22, your firm's environmental samples and finished product testing confirmed the presence of Cronobacter," the report stated.

After the FDA inspectors arrived, "your firm identified the presence of Cronobacter in low-, medium- and high-care areas of powdered infant formula production on 20 occasions between 2/6/22-2/20/22," the report stated.

Water was located in dry areas of the production plant. Abbott "identified 310 water events including water leaks, moisture, and condensation in dry powdered infant formula production areas." Wet areas allow for the growth of the bacteria.

The FDA report said Abbott found cracks and pits in dryers dating back to 2018.

From the inspection report: "FDA and your firm found evidence of Cronobacter spp. in your powdered infant formula production environment. Your firm also identified Cronobacter spp. in finished powdered infant formula products."

FDA also cited the company for failure to retain samples of products it said it tested due to the complaints related to the reported deaths and infections. All those complaints showed the babies infected used products from the Sturgis plant.

As a result of the probe, Abbott Nutrition recalled select lots of its Similac, Alimentum and EleCare formulas.

The recall and stop in production are part of the nationwide baby formula shortage. Both Abbott and the FDA want to bring the plant into safety compliance and restart production as soon as possible.

Cranes working on the Abbott baby formula plant Friday in Sturgis.
Cranes working on the Abbott baby formula plant Friday in Sturgis.
Construction materials  Friday at the Abbott Nutrition plant in Sturgis.
Construction materials Friday at the Abbott Nutrition plant in Sturgis.

This article originally appeared on The Daily Reporter: Congresswoman questions why FDA waited to investigate Abbott in Sturgis