A manufacturer of low-acid canned food (LACF) in the UK was cited for serious deviations of LACF regulations. Wherever its facility is located, a manufacturer of LACF food products intended for export to the United States is required to comply with the FD&C Act and all U.S. regulations relating to the processing of LACF foods.
Citations were issued because the manufacturer made changes to its scheduled processes without the consultation of a process authority, and without filing with the FDA an intentional change to its process schedules. According to regulation, prior to using a changed process, a facility must obtain substantiation by qualified scientific authority as to its adequacy and notify the agency accordingly. Because FDA did not receive any new filings for these products, or any requests to change its currently filed scheduled processes, the warning letter was issued.
