Other infant formula makers besides Abbott have faced Cronobacter contamination and operational deficiencies, documents show
The pathogen that prompted those concerns, Cronobacter sakazakii, can be widely found in the environment -- but in infants, it can be deadly.
Yet within the last five years, those companies -- Reckitt's Mead Johnson, Gerber, and Perrigo's PBM -- have also not been immune to operational and even contamination-related concerns. ABC News has reviewed FDA inspection documents for the three other domestic companies which, along with Abbott, have been responsible for roughly 90% of the country's formula market.
FDA investigators said that company records indicated Cronobacter was found in one of the plant's rooms, and that the area was subsequently sanitized. A plant operator was observed not washing his hands between glove changes, and not changing his gloves between touching non-food and food contact surfaces.
The potential problems the FDA discovered at the plant were addressed in time for later inspections -- but food safety experts told ABC News these issues can become a serious problem if not immediately dealt with. The Zeeland facility submitted a corrective action plan, promising "increased frequency of cleaning the areas where positive results were identified, evaluation and inspection of equipment" and "repairs to equipment and the facility as needed."
Reckitt said they "regularly review and enhance" their facilities' manufacturing processes "and invest in new technologies and equipment," adding that their "robust operating protocols meet or exceed the highest regulatory standards," which they employed while "safely" increasing infant formula amid the shortage.
"We are most interested in how aggressively a firm addresses and responds to potential contamination," the FDA spokesperson said. Lynn said that FDA investigators did what they were supposed to do: identify deficiencies for the companies to fix. A Gerber spokesperson told ABC News that their infant formulas go through up to 500 quality and safety checks, "many of which are above and beyond regulatory requirements."
In a statement to ABC News, Perrigo said they are "proud" of their compliance track record, adding that the Cronobacter within the plant had been found by their own self-monitoring, rather than by FDA investigators. Patrick Stone, a former FDA investigator, says factories that make infant formula should be held to a higher quality-control standard than other mass market food products. But too often, he said, "it actually takes an outbreak or something to happen before people wake up and say .... 'Why is this happening?'"After inspecting Abbott's Sturgis facility earlier this year, FDA chief Dr.
"You don't wait for the accident to happen before you build a stoplight," said Faber, the food safety expert. "You probe your factory for where pathogens could be lurking, and then adopt critical controls to eradicate them. Because there are no national requirements that Cronobacter be reported, doctors and labs are not required to report cases to their local health department -- which leaves the FDA to rely on consumer complaints and health care providers for on-the-ground data regarding infections.
Australia Latest News, Australia Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Did an Abbott Representative Offer Grieving Uvalde Family Money To Oppose Gun Control?Despite citing no sources, evidence, or links of any kind, the three tweets that pushed this rumor still received a massive number of shares. Combined, they were retweeted a total of more than 68,000 times and received more than 244,000 likes.
Read more »
Gov. Abbott spent hours at fundraiser after Uvalde shootingTexas Gov. Greg Abbott has said that he stopped at a campaign fundraiser following the deadly school shooting in Uvalde and “let people know” he couldn’t stay, but a newspaper reports that he was there for nearly three hours.
Read more »
Gov. Abbott tells D.C. mayor to 'stop attacking Texas' as migrant buses create humanitarian crisisThe mayor says she needs help from the National Guard to prevent a spiraling crisis created by Abbott and fellow Republican Gov. Doug Ducey of Arizona. Texas GregAbbott Immigration washingtondc migrants DougDucey Arizona Republicans
Read more »
Texas Gov. Greg Abbott stayed at fundraiser for hours after Uvalde shooting, records showAfter the Uvalde school shooting, Gov. Greg Abbott spent nearly three hours on the ground in Huntsville at a campaign fundraiser that he was criticized for...
Read more »
Quinta Brunson’s ‘Abbott Elementary’ is coming to HBO Max (don’t worry, it’s staying on Hulu, too)Daily News | Quinta Brunson’s ‘Abbott Elementary’ is coming to HBO Max (don’t worry, it’s staying on Hulu, too)
Read more »
Price analysis 7/29: BTC, ETH, BNB, XRP, ADA, SOL, DOGE, DOT, MATIC, AVAXBitcoin price has hit resistance at the $24,000 level, resulting in a slight pullback in select altcoins. Is the rally over?
Read more »