21 CFR 111.570 - Under this subpart O, what records must you make and keep?
(1) Written procedures for fulfilling the requirements of this subpart,
(2) A written record of every product complaint that is related to good manufacturing practice,
(i) The person who performs the requirements of this subpart must document, at the time of performance, that the requirement was performed.
(A) The name and description of the dietary supplement;
(C) The date the complaint was received and the name, address, or telephone number of the complainant, if available;
(D) The nature of the complaint including, if known, how the product was used;
(E) The reply to the complainant, if any; and
(F) Findings of the investigation and followup action taken when an investigation is performed.