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.
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 cronobacter, a rare but potentially deadly bacteria repeatedly linked to outbreaks in baby formula.
— New authority to compel manufacturers to turn over samples and records on manufacturing supply chains, manufacturing quality and safety.
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