US FDA Notes Concerns At Multiple Formula Plants After One Linked To Contamination, Shortage

Commissioner, CFSAN Director Give 'Call To Action' In Letters To Manufacturers

Agency sends letters to manufacturers and other businesses involved in production and distribution “to assist industry in improving the microbiological safety of powdered infant formula.” Information from “routine surveillance inspections” of facilities and “for-cause inspections to follow up on consumer complaints” noted in letters.

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One firm's manufacturing facility has been linked to contaminated powder infant formula products that led to a US supply shortage in 2022 but the Food and Drug Administration has found quality-control problems at plants or other facilities operated by multiple businesses.

The agency has submitted letters to manufacturers and other businesses involved in production and distribution “to assist industry in improving the microbiological safety of powdered infant formula” with information including...

The letters announced on 8 March noted “routine surveillance inspections” of facilities and “for-cause inspections to follow up on consumer complaints.” In addition to manufacturers, the FDA is contacting packers,...

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