CFR Subpart O

CFR Subpart O
in effect

21 C.F.R. § 111.553 What are the requirements under this subpart O for written procedures?

You must establish and follow written procedures to fulfill the requirements of this subpart O.

21 C.F.R. § 111.560 What requirements apply to the review and investigation of a product complaint?

(a) A qualified person must: (1) Review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of this part 111, including those specifications and other requirements that, if not met, may result in a risk of illness or injury; and (2) Investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of this part, including those specifications and other requirements that, if not met, may result in a risk of illness or injury. (b) Quality control personnel must review and approve decisions about whether to investigate a product complaint and review and approve the findings and followup action of any investigation performed. (c) The review and investigation of the product complaint by a qualified person, and the review by quality control personnel about whether to investigate a product complaint, and the findings and followup action of any investigation performed, must extend to all relevant batches and records.

21 C.F.R. § 111.570 Under this subpart O, what records must you make and keep?

(a) You must make and keep the records required under this subpart O in accordance with subpart P of this part. (b) You must make and keep the following records: (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. (ii) The written record of the product complaint must include the following: (A) The name and description of the dietary supplement; (B) The batch, lot, or control number of the dietary supplement, if available; (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.

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