FDA Releases 483 Reports for Infant Formula Manufacturer of Recalled Dried Powder Formula

FDA released its recent inspectional report (FDA 483 Inspectional Observations) dated 1/31-22 to 3/18-22 for Abbott Laboratories' Sturgis Michigan facility. This facity recently recalled baby formula after being linked to 4 infant deaths due to Cronobacter sakazakii. C. sakazakii is a bacterial hazard in baby formula because it can lead to severe infection in death in infants, especially those born prematurely.

From the CDC: "Cronobacter germs can cause a dangerous blood infection (sepsis) or make the linings surrounding the brain and spinal cord swell (meningitis). Infants 2 months of age and younger are most likely to develop meningitis if they get sick from Cronobacter. Other infants more likely to get sick are those born prematurely and those less able to fight germs and sickness because of illness or medical treatment, such as infants receiving chemotherapy for cancer."

A few items from the 483 Report

• FDA found C. sakazakii in the medium and high cares areas on Zone 2 and 3 samples, (with Zone 2 being surfaces adjacent to product contact surfaces and Zone 3 being further away such as floor samples).
• The firm also had positive environmental samples and finished product over a 2.5 year period.
• During inspection, there was a water leak issue in the dryer area, which is supposed to be a dry area. Water issues had been a long identified issue in the facility
• Product contact surfaces were not adequately protected from contamination. (Obs 2)
• Inadequate follow up on consumer complaints (Obs 3)
• Poor adherence to Personal Hygiene program for wearing protective gear (Obs 4) including people failing to sanitize designated work (captive) shoes as they move from area to area.

If you are unfamiliar with a 483 report and the type of issues noted on a report, you may want to check this out.

One thing that stands out is the lack of root cause analysis for issues experienced over time coupled with lax protocols.