The FDA’s recent warning letter to Weifang Sunwoo Foods Co. Ltd. on September 21, from the the director of the Office of Compliance for FDA’s Center for Food Safety and Applied Nutrition put the company on notice of its “serious deviations from the Emergency Permit Control regulation” with regard to the company’s acidified foods. The letter provides some insight regarding practices (or the lack of them) that can trigger notices to food and beverage companies in similar situations. In this situation, the FDA says the manufacturer’s pickled radishes weren’t processed at proper temperatures or for the right length of time.   The letter also stated that the same duration and temperature improprieties arose for the seasoned burdock and seasoned sweet ginger products. Importantly, the letter also points out that proper record keeping for the processing issues and traceability wasn’t maintained:

“Your firm failed to adequately mark each container in accordance with 21 CFR Part 114.80(b). Specifically, your containers are not marked with a code identifying establishment where packed, product contained, year, date and packing period,” …

“Your firm failed to maintain required records in accordance with 21 CFR Part 114.100(e) for a period of three years from the date of product manufacture. Concerning our request for temperature recording data records for a lot of Burdock manufactured on 4/13/2015, your firm replied that you keep computerized records for less than a year on a computerized file.”

The letter is a potent reminder that keeping adequate records is a major part of adequate regulatory compliance, especially if the lack of adequate record keeping gives rise to a presumption of inadequate processing.

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