Since September 2016, domestic and foreign human food facilities have been required to have food safety plans under 21 C.F.R. Part 117, the Hazard Analysis and Risk-Based Preventive Controls for Human Food rule.
“Been there/done that” you say. You appointed a Preventive Controls-Qualified Individual (PCQI), paid for training for the PCQI, had a food safety plan developed by the PCQI, had preventive controls implemented as required with appropriate validation and verification by the PCQI, and have ongoing reviews of monitoring and corrective actions by the PCQI within 7 working days and ongoing reviews of other records, such as calibration, by the PCQI within a reasonable period of time.