Signs are seen in front of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, USA, August 29, 2020. Portal/Andrew Kelly/File Photo Acquire License Rights
Aug 30 (Portal) – The U.S. Food and Drug Administration on Wednesday warned three infant formula makers to correct their manufacturing processes to better catch bacterial contamination, but added that it did not expect any impact on supplies.
The regulator has sent warning letters to ByHeart Inc, Reckitt Benckiser Group’s Mead Johnson Nutrition (RKT.L) and Perrigo’s Wisconsin unit (PRGO.N).
The FDA has sued these companies for failing to establish processes to ensure infant formula is not contaminated during manufacturing.
“We are in the process of carefully reviewing the FDA’s letter and plan to work closely with the agency,” a Perrigo spokesperson said, adding that all infant formula products available to parents and caregivers meet FDA food safety requirements.
The FDA warning letters are not related to current recalls and relate to observations following recalls by the three companies between December and March, the agency said.
The aim of the recalls is to remove products that may be contaminated with the bacteria Cronobacter sakazakii, the FDA added.
“The agency … believes that the recalls helped remove potentially contaminated batches of product from the market,” the FDA said.
Infant formula manufacturing is under increased scrutiny after shortages of the product last year due to the closure of Abbott Laboratories’ (ABT.N) unit in Michigan.
The formulas manufactured at the Abbott plant faced complaints of bacterial infections, leading to recalls and closure.
Reckitt and ByHeart did not immediately respond to requests for comment.
Reporting by Leroy Leo in Bengaluru; Edited by Krishna Chandra Eluri
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