It is unclear when the facility will restart production
The company ramped up production of the formula for infants with severe food allergies and digestive problems prior to the second shut down.
The factory was damaged and needs re-sanitizing following severe thunderstorms and heavy rains that moved through Michigan on Monday. The company did not specify the extent of the damage to the facility.
“Severe thunderstorms and heavy rains came through southwestern Michigan on Monday evening, resulting in high winds, hail, power outages and flood damage throughout the area,” Abbott said in a statement Wednesday night. “These torrential storms produced significant rainfall in a short period of time – overwhelming the city’s stormwater system in Sturgis, Mich., and resulting in flooding in parts of the city, including areas of our plant.”
US Food and Drug Administration Commissioner Dr Robert Califf said in a tweet that the agency would be working alongside Abbott to get the facility back up and producing as soon as possible.
“We know Abbott is working quickly to assess the damage and will be reporting its progress to us in the days ahead. Once the company establishes a plan, FDA will be back in the facility working to ensure that they can restart producing safe and quality formula products quickly," hy het geskryf.
Abbott restarted production at the factory on 4 June after contamination issues forced it to close back in February, which ultimately was a major factor in the formula shortage plaguing the nation.
In Februarie, the Food and Drug Administration launched an investigation into four bacterial infections that affected infants who consumed the factory’s powdered formulas. Two of those babies died, which resulted in the closure.
The company has insisted that its products were not directly related to the infections.
FDA inspectors ultimately found numerous violations at the plant, including bacterial contamination, leaks in the roof, and insufficient safety protocols.
Following the inquiry, Abbot recalled several of its leading brands, including Similac.
The company has not said when its facility would re-open.
“As a result, Abbott has stopped production of its EleCare specialty formula that was underway to assess damage caused by the storm and clean and re-sanitize the plant,” het die maatskappy gesê. “We have informed FDA and will conduct comprehensive testing in conjunction with the independent third party to ensure the plant is safe to resume production. This will likely delay production and distribution of new product for a few weeks.”