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
WASHINGTON — — , according to federal records reviewed by The Associated Press.
Abbott resumed production at the plant early this month under a legally binding agreement with the FDA, but the shutdown and nationwide shortage exposed how concentrated the industry has become in the U.S., with a handful of companies accounting for roughly 90% of the market. 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. Longtime food safety specialists see a deeper problem at the highest levels of the FDA, where physicians and medical scientists for decades have prioritized oversight of drugs and medical products over food.
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