Many baby formula plants weren't inspected because of COVID
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., according to agency records. All those facilities are operating around the clock to boost U.S. formula production.
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. FDA Commissioner Robert Califf says regulators knew shutting down Abbott’s plant would create supply problems, but there was little evidence of urgency between when inspectors shuttered the plant in February and recent emergency measures to allow more imports from abroad.
There’s no certainty that extra inspections during COVID-19 would have prevented the contamination problems at the Sturgis, Michigan, plant that was shut down. And Abbott says that its products have not been directly linked to the infections, two of which were fatal.
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