FDA Inspection Report Reveals Product Spoilage, Record-Keeping FlawsEarlier this month, Unilever announced a recall of all of its Slim-Fast ready-to-drink products, after finding Bacillus cereus contamination in the beverage.
Immediately following the recall announcement, FDA conducted a 7-day inspection of Unilever's Covington, TN Slim-Fast processing facility. The summary of FDA's findings was released this week.
The good news is that inspectors did not uncover any indication of underprocessing. That is, the product was "cooked" according to specification.
The bad news is that the Covington processing facility recorded instances of product spoilage ("sours") as long ago as September. A second occurrence, which was documented in mid-November, may have been the trigger for the recall announcement.
In addition to the instances of product spoilage, FDA inspectors noted flaws in the facility's record keeping, including:
- Entries on aseptic system processing records were not made at the time the specific processing system operation occurred.
- Process deviations were not recorded in a separate file or log that details both the deviation and the actions taken.
- Investigations of elevated kick out/reject rates and Spoilage Reports have not been adequately described and documented, and no HOLD log is available to track and verify investigations of such incidents.
The investigation report does not suggest how or when Bacillus cereus found its way into some cans of Slim-Fast. There is no mention of finished product or environmental sampling results. That work probably was carried out by Unilever's Corporate Quality Assurance trouble-shooters, and would not appear in the FDA report.
Slim-Fast consumers – and Unilever – are fortunate that the contaminant was Bacillus cereus, and not a more potent pathogen, such as Clostridium botulinum.
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