The gap in baby formula plant inspections is getting new scrutiny from Congress and government watchdogs investigating the series of missteps that led to the crisis.
U.S. regulators have historically inspected baby formula plants at least once a year, but they did not inspect any of the three biggest manufacturers in 2020, according to federal records reviewed by The Associated Press.
As COVID-19 swept across the U.S. in early 2020, the FDA pulled most of its safety inspectors from the field, skipping thousands of routine plant inspections. The inspection records reviewed by the AP show gaps as large as 2 1/2 years between FDA's 2019 inspections and when regulators returned to plants owned by the three leading formula manufacturers: Abbott, Reckitt and Gerber.
Under current law, the FDA is only required to inspect formula facilities every three to five years, but the agency has consistently inspected facilities annually — until the pandemic. "It's very challenging for them to get engaged at all in this area because they don't have the background, the knowledge and the experience in it," said Steven Mandernach, executive director of the Association of Food and Drug Officials, which represents state-level inspectors.
But the plant did have earlier problems, including a 2010 formula recall due to possible contamination with insect parts.
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