An FDA inspection of Chobani’s yogurt production facility in Twin Falls, Idaho, conducted after it recalled some products last fall, found “minor” deficiencies in good manufacturing practices (GMPs), but nothing to warrant issuing a ‘483’ letter, the agency has confirmed.
Speaking to FoodNavigator-USA after the publication of a controversial paper in mBio (click HERE ) about a fungal contaminant found in some Chobani products last year, an FDA spokesman said the agency had received 403 complaints about Chobani products, but said a 483 form had not been issued following an inspection of the plant between Sept 5 and 18.
483 forms are issued where violations of the Food Drug and Cosmetic (FD&C) Act are suspected and investigators fear products are being produced under conditions that may cause health problems.
FDA report: A mold growth of Mucor circinelloides was plated
In a report - which you can read HERE - the agency claimed that problems were first detected at the plant in July 2013 when routine sampling by the Idaho Dept of Agriculture found a “yeast-like growth developing in the yogurt samples”.
At this point, says the FDA report, Chobani “began an equipment cleaning regimentation but found the problem was being reduced but not stopped”. Samples were then sent to an unspecified lab (the name is redacted) “where a mold growth of Mucor circinelloides was plated".
Chobani cleaned its entire facility from top to bottom, and revised its sampling and testing procedures, said the report. Cleaning records were “carefully analyzed for any deviations from the protocol and all the records were found satisfactory”, while environmental sampling/swabbing protocol was “precise and regimented”.
It is difficult for FDA to fully evaluate whether the product caused the adverse event or simply coincided with it
Asked about adverse event reports associated with the incident, the FDA spokesman stressed that they did not prove “whether the product actually caused the adverse events”.
He added: “Reports submitted to FDA vary in quality and reliability. Some do not include all relevant data, such as whether an individual also suffered from other medical conditions or used other products or medications at the same time.
And this made it “difficult for FDA to fully evaluate whether the product caused the adverse event or simply coincided with it”.
In late August 2013, Chobani withdrew selected products made at the Twin Falls plant with a best before date of Sept 11 to Oct 7 from the vast majority of its retail/distributor customers. On September 5, 2013, it voluntarily initiated a nationwide recall.
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