Comments Sought on Dietary Supplement Recordkeeping

Federal Register notice: FDA has asked for comments on an information collection: “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111.” Records required by FDA’s regulations in Part 111 provide the foundation for the planning, control, and improvement processes that constitute a quality control system. They show what is to be manufactured; what was, in fact, manufactured; and whether the controls that the manufacturer put in place to ensure the identity, purity, strength, and composition and limits on contaminants and to prevent adulteration were effective. Further, records will show whether and what deviations from control processes occurred, and facilitate evaluation and corrective action concerning these deviations. To view the notice, click here.