Abbott plans to restart production at its formula plant in Sturgis, Michigan on June 4th, according to a company press release.
Abbott also releasing around 300,000 cans of EleCare Specialty Formula on a case-by-case basis, according to the Food and Drug Administration.
In a press release, the FDA said it is not objecting to the release of about 300,000 cans of EleCare amino acid-based infant formula previously produced at Abbott Nutrition’s Sturgis, Michigan, facility to individuals needing urgent, life-sustaining supplies.
These EleCare product lots were not part of the recall, but have been on hold due to concerns that they were produced under insanitary conditions observed at Abbott Nutrition’s Sturgis, Michigan, facility.
Any product released from the Sturgis facility will undergo enhanced microbiological testing first, the FDA said.
EleCare will also be the first formula produced at the Sturgis Facility when it restarts production. Other specialty formulas will closely follow.
Abbott said initial EleCare product release will begin on or about June 20th.
EleCare formulas are hypoallergenic and are used by infants and children who have severe food allergies or gastrointestinal (GI) disorders that require amino acid-based formulas, according to Abbott.
Under the consent decree with the FDA, Abbott is required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law, the administration added.
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