Are You Prepared for an Out of Specification (OOS) Investigation?

oos investigation on baby formula shortage

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The inability to find baby formula to feed their child has been an especially stressful reality for many parents and caregivers in recent months. Earlier this year, pandemic-related supply-chain issues and ingredient shortages led to some formulas being out of stock around the country. The problem only grew worse when in February of 2022, the Food and Drug Administration began hearing complaints and reports of several infants becoming severely ill after drinking infant formula from the Abbott Nutrition facility in Sturgis, Michigan. While Abbott, which produces 48% of the infant formula sold in the US – of which about half is produced at their Sturgis, Michigan facility – voluntarily recalled a number of its products, after FDA inspections, they closed the facility. Several months later, with the loss of the Michigan plant supply, significant formula shortages were reported and became a big news story. Had the facility employed Good Manufacturing Practices, this all could have been avoided.

While Abbott bears a large part of the blame for what led to the shortage, the FDA has come under fire from Capitol Hill and consumers alike. Recently, during House Energy and Commerce Committee hearings, members lambasted the FDA which they say have allowed long-standing structural flaws to fester. The food safety division of the agency, according to experts, has been chronically understaffed and underfunded. Those problems, critics say, have been exacerbated by poor communication between its centers. More broadly, experts say, the agency has prioritized the drug and medicine side, frequently drawing leaders with medical backgrounds and not food industry knowledge.

The failures of the FDA in this particular case are manifold. While the first consumer complaints began in 2019, it wasn’t until 2022 that the FDA concluded Abbott had failed to maintain a clean and safe environment. A whistleblower warned the FDA in October 2021 that Abbott falsified records, released untested formula, were lax in their cleaning practices, misled auditors, failed to take corrective measures and lacked good systems for tracing potentially contaminated products. Investigators now report that the FDA waited months to inspect the Abbott facility after learning its formula could be contaminated and, after its inspectors confirmed the contamination, the FDA waited for weeks before alerting the public.

The infant formula crisis is partly the result of a bigger crisis at the FDA. Despite major food safety reforms enacted by Congress in 2011, our food supply may not be any safer than it was then. Since 2011, food outbreaks have gradually increased – at least until the Covid-19 pandemic dramatically changed our eating habits. As the incidence of pathogens has gone up, so has the number of outbreaks. And there are still hundreds of recalls every year. To prioritize food safety at the FDA, Congress must address the fragmented leadership at the top of the agency and provide more funding for FDA’s food safety center.

To avoid running into these types of issues for your facility, download our free OOS checklist!

Download the Out of Specification (OOS) Investigation Checklist

Click here to download a copy of the Out of Specification (OOS) Investigation Checklist. This checklist outlines what to look for.

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