WASHINGTON (AP) — Federal safety inspectors say baby formula maker Abbott failed to maintain sanitary conditions at the Michigan manufacturing plant recently linked to a cluster of infant illnesses.
The Food and Drug Administration began investigating the plant after Abbott recalled several leading infant formulas.
The products have been tied to four infant hospitalizations, including two deaths, due to a rare bacterial infection.
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FDA inspectors released their initial findings Tuesday evening.
The following observations were noted:
- "You did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment."
- "You did not ensure that all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source."
- "Your investigation file on a complaint did not include the determination as to whether a hazard to health exists and the basis for that determination."
- "Personnel working directly with infant formula, its raw materials, packaging, or equipment or utensil contact surfaces did not wear necessary protective apparel."
Among other problems, they found a history of contamination with the bacteria in various parts of the plant. But the FDA report doesn't identify a root cause for the latest outbreak.
Recall info below:
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