A 10-page report from the agency offers its first formal account of the factors that led to the ongoing shortage.
A company whistleblower had tried to warn the FDA of problems at the plant in September 2021, but government inspectors didn’t investigate the complaints until February after four infants became sick, resulting in two deaths. The FDA is still investigating links between those illnesses and the formula.that top agency officials didn’t learn about the complaint until February because of mail delays and a failure to escalate the Abbott employee’s allegations.
“Whistleblower complaints come into the agency in many different ways, from many different sources,” said Dr. Steven Solomon, an FDA veterinary medicine official who oversaw the review. “One of the actions we’ve already taken is to make sure that however they come into the agency, they get triaged and escalated to the right leadership levels.”
FDA inspectors collected bacterial samples from the plant for testing, but shipping issues by “third party delivery companies” delayed the results, according to the report. The FDA also faced challenges ramping up its testing capacity for, a rare but potentially deadly bacteria repeatedly linked to outbreaks in baby formula.
The FDA also noted that it had to reschedule its initial inspection of the Abbott plant due to cases of
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