21 CFR §121.145

1. (a)Food defense corrective action procedures. As appropriate to the nature of the actionable process step and the nature of the mitigation strategy:
   1. (1)You must establish and implement written food defense corrective action procedures that must be taken if mitigation strategies are not properly implemented.
   2. (2)The food defense corrective action procedures must describe the steps to be taken to ensure that:
      1. (i)Appropriate action is taken to identify and correct a problem that has occurred with implementation of a mitigation strategy; and
      2. (ii)Appropriate action is taken, when necessary, to reduce the likelihood that the problem will recur.
2. (b)Records. All food defense corrective actions taken in accordance with this section must be documented in records that are subject to food defense verification in accordance with § 121.150(a)(2) and records review in accordance with § 121.150(a)(3)(i).